Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 42 to 72 days
• All sexes
• Healthy volunteers accepted
• Child

Trial locations and contacts

12 sites in 1 country.

About this study

Official title: A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India

Conditions

Pneumococcal Infections

Being tested

13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine

Keywords

Vaccines, Pneumococcal

Medical subject headings

Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 13-valent Pneumococcal Conjugate VaccineBiological

  1 dose at 6, 10, 14 weeks and 12 months of age

• 7 valent pneumococcal conjugate vaccineBiological

  1 dose at 6, 10, 14 weeks and 12 months of age

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.

   Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.

   Measured: 1 month after the infant series (18 weeks of age)

2. Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.

   Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.

   Measured: 1 month after the infant series (18 weeks of age)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Mar 2007 (estimated)
2. Study startJun 2007
3. Primary completionOct 2009
4. Study completionFeb 2010

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.