20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
- Conditions
- Pneumococcal InfectionsMedDRA version: 21.1Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-003307-35-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1500
Age and Sex:
1. Male or female infants born at =34 weeks of gestation and who are 2 months of age (=42 to =98 days) at the time of consent (the day of birth is considered day of life 1).
Type of Participant and Disease Characteristics:
2. Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
4. Expected to be available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
Informed Consent:
5. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Medical Conditions:
1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid–containing vaccine.
2. 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’s palsy and/or hypotonic-hyporesponsive episodes.
3. Major known congenital malformation or serious chronic disorder.
4. Known or suspected immunodeficiency or other conditions associated with immunosuppression, including but not limited to, immunoglobulin class/subclass deficiencies, DiGeorge syndrome, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
5. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
6. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Prior/Concomitant Therapy:
7. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
8. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt through the visit occurring 1 month after Dose 4 (Visit 6). If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
Prior/Concurrent Clinical Study Experience:
9. Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
10. Children or grandchildren who are direct descendants of investigator site staff members or Pfizer employees who are directly involved in the conduct of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary safety objective: <br>• To describe the safety profile of 20vPnC<br><br>;Secondary Objective: Exploratory objective:<br>• To describe the safety profile of 20vPnC in subgroups;Primary end point(s): a. Prompted local reactions (redness, swelling, and pain at the injection site).<br>b. Prompted systemic events (fever, decreased appetite, irritability, and drowsiness/increased sleep).<br>c. Adverse events (AEs)<br>d. Serious adverse events (SAEs)<br>e. Newly diagnosed chronic medical conditions (NDCMCs)<br>;Timepoint(s) of evaluation of this end point: a. within 7 days after each dose <br>b. within 7 days after each dose <br>c. from Dose 1 through 1 month after Dose 3 and from Dose 4 through 1 month after Dose 4 <br>d. up to 6 months after Dose 4 <br>e. up to 6 months after Dose 4
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Same as the primary safety endpoints;Timepoint(s) of evaluation of this end point: Same timepoints as for the primary safety endpoints