Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00464945
• Date of registration: 23/04/2007
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
• Scientific title: A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
• Date of first enrolment: June 2007
• Target sample size: 269
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00464945
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Poland

Contacts

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

• Name: Trial Manager
• Affiliation: For Poland, [e-mail]

Key inclusion & exclusion criteria

Inclusion criteria:

1. Aged 2 months (42 to 98 days) at time of enrollment.

2. Available for entire study period and whose parent/legal guardian can be reached by
telephone.

3. Healthy infant as determined by medical history, physical examination, and judgment of
the investigator.

4. Parent/legal guardian must be able to complete all relevant study procedures during
study participation.

Exclusion criteria:

1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate,
diphtheria, tetanus, pertussis, or polio vaccines.

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

3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

5. Known or suspected immune deficiency or suppression.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorders.

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 palsy.

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

10. Participation in another investigational or interventional trial. Participation in
purely observational studies is acceptable.

11. Infant who is a direct descendant (child or grandchild) of a member of the study site
personnel.



Age minimum: 41 Days
Age maximum: 99 Days
Gender: All

Health Condition(s) or Problem(s) studied

Pneumococcal Vaccines

Intervention(s)

Biological: 13-valent Pneumococcal Conjugate Vaccine

Primary Outcome(s)

Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (5 months of age)]

Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) [Time Frame: During the 4-day period after toddler dose]

Percentage of Participants Achieving Antibody Level =0.35µg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (5 months of age)]

Percentage of Participants Reporting Pre-Specified Local Reactions [Time Frame: During the 4-day period after each dose]

Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) [Time Frame: During the 4-day period after each dose]

Secondary ID(s)

6096A1-3000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00464945