Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00452452
• Date of registration: 23/03/2007
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
• Scientific title: A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
• Date of first enrolment: July 2007
• Target sample size: 355
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00452452
• 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 from 7 months to <72 months at time of enrollment.

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

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

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

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

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

3. Contraindication to vaccination with pneumococcal vaccine.

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 monoclonal antibodies) in the
last 3 months.

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

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



Age minimum: 7 Months
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumococcal Infections

Intervention(s)

Biological: 13-valent Pneumococcal Conjugate Vaccine

Primary Outcome(s)

Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups [Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).]

Percentage of Participants Achieving Antibody Level =0.35µg/mL After Vaccination [Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).]

Secondary Outcome(s)

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

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

Secondary ID(s)

6096A1-3002

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/NCT00452452