A Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study Evaluating the Safety, Tolerability, and Immunogenicity of an Oral Inactivated ETEC Vaccine (ETVAX) Alone and Together With dmLT Adjuvant in Descending Age Groups in Bangladesh
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 2
- 主要终点
- Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine
研究概览
简要总结
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
详细描述
This Phase I/II trial will serve to assess whether ETVAX is safe and provides mucosal as well as systemic immune responses against the key protective antigens when tested in different age-groups in Bangladesh. This study provides an opportunity to test the safety profile of a mucosal adjuvant, double-mutant LT (dmLT), in adults and children, as well as provide the opportunity to potentially assess the ability of dmLT to further enhance the mucosal and systemic antibody responses to key antigens in the ETVAX vaccine among age groups in developing country sites, like Bangladesh, that have proved refractory to oral immunization with enteric vaccines. In addition, this study also allows for the evaluation of the potential dose-sparing effect of dmLT when combined with a lower dose of vaccine. Finally, this clinical trial is considered an essential study along the critical path of the overall clinical development plan before determining whether the vaccine can be tested for protective efficacy in children in developing countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults 18-45 years old, inclusive
- •General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination
- •Properly informed about the study, able to understand it and sign or thumb print the informed consent form
- •Available for the entire period of the study and reachable by study staff throughout the entire follow-up period
- •Females of childbearing potential who are willing to take a urine pregnancy test at screening and before the second vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable.
- •Informed Consent (signature or thumb print provided, with witness signature)
排除标准
- •Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
- •History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment
- •Screening positive with hepatitis B antigen and/or hepatitis C antibodies
- •Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product
- •Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician
- •History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)
- •Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins
- •Evidence of current illicit drug use or drug dependence
- •Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug
- •Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
- •Receipt of antimicrobial drugs for any reason within 14 days before vaccination
- •History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea)
- •Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination.
- •Acute disease at the time of enrollment or 3 days prior to enrollment
- •History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids.
- •Children, Toddlers and Infants Inclusion Criteria
- •Healthy male or female infants/toddlers/children ages:
- •Part B: >24 and ≤59 months old at the time of enrollment
- •Part C: ≥12 and <24 months old at the time of enrollment
- •Part D: ≥6 and <12 months at the time of enrollment
- •General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination
- •Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form
- •Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period
- •Informed Consent (signature or thumb of parent, with signature of witness, provided)
- •Exclusion Criteria
- •Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
- •History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment
- •Screening positive with hepatitis B antigen and/or hepatitis C antibodies
- •Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product
- •Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician
- •History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)
- •Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins
- •Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug
- •Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
- •Receipt of antimicrobial drugs for any reason within 14 days before vaccination
- •History of diarrhea during the 7 days before vaccination (see Protocol definition of diarrhea))
- •Culture positive for ETEC, Shigella, V. cholerae, Salmonella or Rotavirus (the latter for all children <5 years of age) within 7 days of vaccination
- •Acute disease at the time of enrollment or 3 days prior to enrollment
- •Known or suspected impairment of immunological function based on medical history and physical examination
- •Participant's parents/guardians not able, available or willing to accept active weekly follow-up by the study staff
- •History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
- •Any medical condition in the child/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent
- •Medically significant malnutrition, defined as moderate malnutrition (wt-for-ht z-score between -3.0 and -2.0) and severe malnutrition (wt-for-ht z-score <-3.0 or edema)
研究组 & 干预措施
12-23 months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
12-23 months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
6-11 months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
12-23 months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
24-59 months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
24-59 months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
24-59 months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
12-23 months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: dmLT (Biological)
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
6-11 month olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: Bicarbonate Buffer (Other)
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
24-59 months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
6-11 months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
6-11 months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
干预措施: ETVAX (Biological)
结局指标
主要结局
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine
时间窗: 6 months ± 14 days after the first dose
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity
时间窗: 7 days after each vaccination (Day 7 and Day 21)
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.
次要结局
- Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen(19 days)
- Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen(19 days)
- Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX(19 days)
- Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen(19 days)
- Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen(19 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen(28 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen(28 days)
- Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen(28 days)
- Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen(28 days)
- Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX(19 days)
- Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX(19 days)
- Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX(19 days)
- Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen(19 days)
- Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults(19 days)
- Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults(19 days)
- Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose(19 days)
- Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose(19 days)
- Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose(19 days)
- Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects(19 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen(7 days)
- Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects(19 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen(19 days)
- Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen(19 days)
- Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen(19 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen(28 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen(7 days)
- Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen(7 days)
- Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen(7 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen(Day 19)
- Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen(28 days)
- Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen(28 days)
- Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen(28 days)