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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80; Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366548

6096A1-009

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 manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Enrollment: 500 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 2 months (42 through 98 days) at the time of enrollment.
2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. In good health as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s)/legal guardian(s) were 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, or polio vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, 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.
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, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80

2

Active Comparator group

Treatment:

Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80