Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 7-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366340

6096A1-006

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Enrollment: 604 patients

Sex: All

Ages: 56 to 112 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 2 months (56 to 112 days) at time of enrollment.
2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
8. Major known congenital malformation or serious chronic disorder.
9. 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. Did not include resolving syndromes due to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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604 participants in 2 patient groups

1

Experimental group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

2

Active Comparator group

Description:

7-valent pneumococcal conjugate vaccine

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine