A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Reporting Pre-Specified Local Reactions
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 42 Days to 98 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
- •In good health as determined by medical history, physical examination and judgment of the investigator,
- •Subject must have been born ≥36 weeks of gestational age,
- •Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
- •Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.
Exclusion Criteria
- •Previous vaccination with licensed or investigational pneumococcal vaccine,
- •Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
- •Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
- •Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy,
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
- •History of culture-proven invasive disease caused by S. pneumoniae,
- •Previous anaphylactic reaction to any vaccine or vaccine components,
- •Major known congenital malformation or serious chronic disorders,
- •Participation in another investigational study (however, observation-only trials are permitted),
- •Known or suspected immune deficiency/suppression,
- •Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).
Outcomes
Primary Outcomes
Percentage of Participants Reporting Pre-Specified Local Reactions
Time Frame: Within 15 days after each dose
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events
Time Frame: Within 15 days after each dose
Systemic events (fever \[Fv\] ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time Frame: one month after 3-dose infant series (at 7 months of age)
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Secondary Outcomes
- Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(One month after the toddler dose (13 to 16 months of age))
- Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series(one month after the infant series (7 months of age))
- Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series(One month after 3-dose infant series (at 7 months of age))
- Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series(One month after the infant series (7 months of age))
- Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series(one month after the infant series (7 months of age))
- Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(One month after the toddler dose (at 13 to 16 months of age))
- Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose(Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age))
- Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series(one month after the infant series (7 months of age))
- Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series(one month after the infant series (7 months of age))
- Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series(one month after the infant series (7 months of age))
- Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series(one month after the infant series (7 months of age))
- Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(One month after the Toddler Dose (13 to 16 months of age))