Pneumococcal InfectionsPhase 3NCT00452790

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

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine and 7 valent pneumococcal conjugate vaccine in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 12 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India. Read more about this study

Who is it for?: Ages 42 to 72 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: 13-valent Pneumococcal Conjugate Vaccine and 7 valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 708 participants
Where: 12 sitesIndia
Study dates: Jun 2007to Feb 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Healthy infants aged 6 weeks (42-72 days) at time of enrolment
Available for the entire study period

Who cannot join

Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
A previous anaphylactic reaction to any vaccine or vaccine-related component
Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

India12 sites

Study site
Bangalore, Karnataka, 560 034
Study site
Bangalore, Karnataka, 560017
Study site
Chennai, Tamil Nadu, 600034
Study site
Ludhiana, Punjab, 141008
Study site
Mumbai, Maharashtra, 400 026
Study site
Pune, Maharashtra, 411 043
Study site
Pune, Maharashtra, 411001
Study site
Pune, Maharashtra, 411011
Study site
Rajinder Nagar, New Delhi, 110 060
Study site
Sector-12, Chandigarh, 160 012
Study site
Sector-32 B, Chandigarh, 160031
Study site
Vellore, Tamil Nadu, 632 004

Other trials in India

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

Study groups in NCT00452790
Study group	Role	What they receive
A	Experimental	Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
B	Active comparator	Not described Receives: Biological: 7 valent pneumococcal conjugate vaccine

What is being measured

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

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)
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)

Secondary outcomes (1)

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% 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 toddler dose (13 months of age)

Timeline

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

Jun 2007Feb 2010

First posted27 Mar 2007 (estimated)
Study startJun 2007
Primary completionOct 2009
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.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 708 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00452790
Sponsor's protocol ID: 6096A1-011
Status last verified: Mar 2011
First submitted: 23 Mar 2007
Last updated: 21 Sep 2026
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
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Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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RecruitingObservational study
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00452790
Acronym / sponsor ID: 6096A1-011
Conditions: Pneumococcal Infections
Keywords: Vaccines, Pneumococcal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 708 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Oct 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 27 Mar 2007 (estimated)
Results: Posted 15 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
B	Active comparator	Biological: 7 valent pneumococcal conjugate vaccine

Who may qualify

Ages: 42 to 72 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy infants aged 6 weeks (42-72 days) at time of enrolment
Available for the entire study period

Key exclusion criteria (3 listed)

Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
A previous anaphylactic reaction to any vaccine or vaccine-related component
Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent Pneumococcal Conjugate Vaccine1 dose at 6, 10, 14 weeks and 12 months of age	Biological	A
7 valent pneumococcal conjugate vaccine1 dose at 6, 10, 14 weeks and 12 months of age	Biological	B

Primary outcome

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.
Time frame: 1 month after the infant series (18 weeks of age)
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.
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.
Time frame: 1 month after the infant series (18 weeks of age)
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.

1 secondary outcome

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose.
Time frame: 1 month after the toddler dose (13 months of age)

Results and safety

Results posted to the registry on 15 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	354	219
7vPnC	355	214

Primary outcome: 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.

Time frame: 1 month after the infant series (18 weeks of age). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC n = 206	7vPnC n = 196
Common serotypes - serotype 4 (n= 203, 192)	97.0 (93.6 to 98.9)	97.9 (94.7 to 99.4)
Common serotypes - serotype 6B (n= 196,194)	84.7 (78.8 to 89.5)	87.1 (81.5 to 91.5)
Common serotypes - serotype 9V (n= 204,195)	92.6 (88.1 to 95.8)	94.4 (90.1 to 97.2)
Common serotypes - serotype 14 (n= 185,186)	91.4 (86.3 to 95.0)	93.5 (89.0 to 96.6)
Common serotypes - serotype 18C (n= 204,188)	95.1 (91.1 to 97.6)	93.1 (88.4 to 96.3)
Common serotypes - serotype 19F (n= 200,188)	95.0 (91.0 to 97.6)	94.7 (90.4 to 97.4)
Common serotypes - serotype 23F (n= 202,186)	90.1 (85.1 to 93.9)	89.2 (83.8 to 93.3)
Additional serotypes - serotype 1 (n= 206,195)	96.6 (93.1 to 98.6)	0.5 (0.0 to 2.8)

Population analysed: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.

Primary outcome: 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.

Time frame: 1 month after the infant series (18 weeks of age). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC n = 206	7vPnC n = 196
PT >=0.975 EU/mL	100.0 (98.2 to 100.0)	100.0 (98.1 to 100.0)
FHA >=3.91 EU/mL	100.0 (98.2 to 100.0)	100.0 (98.1 to 100.0)
PRN >=6 EU/mL	92.7 (88.2 to 95.9)	95.9 (92.1 to 98.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infant Series 13vPnC	8 of 353 (2.3%)	330 of 353 (93.5%)	Not reported
Infant Series 7vPnC	6 of 353 (1.7%)	316 of 353 (89.5%)	Not reported
After the Infant Series 13vPnC	8 of 353 (2.3%)	5 of 353 (1.4%)	Not reported
After the Infant Series 7vPnC	11 of 353 (3.1%)	9 of 353 (2.5%)	Not reported
Toddler Dose 13vPnC	4 of 198 (2%)	98 of 198 (49.5%)	Not reported
Toddler Dose 7vPnC	1 of 200 (0.5%)	98 of 200 (49%)	Not reported

Limitations and caveats (from the sponsor): Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumococcal Infections

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 1 month after the infant series (18 weeks of age)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.