Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

Pfizer

Status and phase: Completed; Phase 4

Conditions: Vaccines

Treatments: Biological: 13vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03548337

2016-005134-29 (EudraCT Number)

INDIA INFANT MDV (Other Identifier)

B4671004

Details and patient eligibility

About

A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

Full description

A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

Enrollment: 301 patients

Sex: All

Ages: 42 to 72 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.)
4. Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
6. Weight of 3.0 kg or greater at the time of vaccination.

Exclusion criteria

1. Infant who is a direct descendant (child, grandchild) of

   • Investigator site staff members directly involved in the conduct of the study, or
   • Site staff members otherwise supervised by the investigator, or
   • Pfizer employees directly involved in the conduct of the study.

2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.

3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.

4. A previous anaphylactic reaction to any vaccine or vaccine-related component.

5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.

7. Major known congenital malformation or serious chronic disorder.

8. 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.

9. Other acute or chronic medical condition including recent 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 subject inappropriate for entry into this study.

10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups

13vPnC with 2-PE from a MDV

Active Comparator group

Description:

Multi Dose Vial with preservative

Treatment:

Biological: 13vPnC

13vPnC without 2-PE in a PFS

Active Comparator group

Description:

Pre Filled Syringe without preservative

Treatment:

Biological: 13vPnC