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New infant vaccine targets 13 strains of pneumonia bacteria

NCT ID NCT00452790

NEW Vaccine Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a 13-valent pneumococcal conjugate vaccine is safe and prompts a strong immune response in healthy infants in India. The trial enrolls 708 infants who receive the vaccine or an older seven-strain version alongside their routine childhood shots. The goal is to see how well infants develop protective antibody levels against the targeted pneumococcal strains and other routine vaccine antigens.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a 13-valent pneumococcal conjugate vaccine
What this could lead to
If it works, this vaccine could broaden protection for infants against more strains of pneumococcal bacteria than the older seven-strain shot.
What could go wrong
The trial compares two vaccines, so the new one may not outperform the older one. As with any vaccine, some infants may have reactions such as fever or soreness at the injection site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

708 people

The number who actually took part.

Start date

Jun 2007

Finished

Feb 2010

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

42 to 72 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment 2. Available for the entire study period Exclusion Criteria 1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines 2. A previous anaphylactic reaction to any vaccine or vaccine-related component 3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

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Conditions

The condition(s) this trial relates to.

pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal infections

Contacts and locations

Locations

  • Study site

    Sector-12, Chandigarh, 160 012, India

  • Study site

    Sector-32 B, Chandigarh, 160031, India

  • Study site

    Bangalore, Karnataka, 560 034, India

  • Study site

    Bangalore, Karnataka, 560017, India

  • Study site

    Mumbai, Maharashtra, 400 026, India

  • Study site

    Pune, Maharashtra, 411 043, India

  • Study site

    Pune, Maharashtra, 411001, India

  • Study site

    Pune, Maharashtra, 411011, India

  • Study site

    Rajinder Nagar, New Delhi, 110 060, India

  • Study site

    Ludhiana, Punjab, 141008, India

  • Study site

    Chennai, Tamil Nadu, 600034, India

  • Study site

    Vellore, Tamil Nadu, 632 004, India

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