ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00368966
Date of registration:	25/08/2006
Prospective Registration:	Yes
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Scientific title:	A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain
Date of first enrolment:	October 2006
Target sample size:	619
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00368966
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Spain

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Spain, infomed@wyeth.com

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy 2-month-old infants

- Available for the entire study period

Exclusion criteria:

- Previous vaccination with any vaccine before the start of the study

- Known contraindication to vaccination

Age minimum: 42 Days
Age maximum: 98 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal

Intervention(s)

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 7-valent Pneumococcal Conjugate Vaccine

Primary Outcome(s)

Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)]

Percentage of Participants Achieving Antibody Level = 0.35 Microgram Per Milliliter (µg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]

Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)]

Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]

Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)]

Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of = 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [Time Frame: One month after 2-doses of the infant series (5 months of age)]

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

Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [Time Frame: One month after 2-doses of the infant series (5 months of age)]

Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)]

Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [Time Frame: One month after 2-doses of the infant series (5 months of age)]

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

Secondary Outcome(s)

Secondary ID(s)

6096A1-501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	16/08/2012
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00368966

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.