Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

Pfizer

Status and phase: Completed; Phase 3

Conditions: Healthy Subjects

Treatments: Biological: DTaP; Biological: 7-valent pneumococcal conjugate vaccine (7vPnC); Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200368

B1851056

6096A1-3024 (Other Identifier)

Details and patient eligibility

About

Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.

Enrollment: 551 patients

Sex: All

Ages: 3 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 3 to 6 months of age at the enrollment.
• Available for the entire study period and whose parent/legal guardian can be reached by telephone.
• Healthy infant as determined by medical history, physical examination, and judgement of the investigator.

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
• History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
• Infant who is a direct descendant (child, grandchild) of the study site personnel.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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551 participants in 3 patient groups

1

Experimental group

Description:

Experimental

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

2

Active Comparator group

Description:

Active comparator

Treatment:

Biological: DTaP

Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

Biological: DTaP

3

Active Comparator group

Description:

Active comparator

Treatment:

Biological: DTaP

Biological: DTaP