VaccinesPhase 3NCT00688870

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (13vPnC) and 7-valent pneumococcal conjugate vaccine (7vPnC) in people with Vaccines and Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Taiwan.

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), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan. Read more about this study

Who is it for?: Ages 42 to 98 days
Conditions the study is for: Vaccines, Pneumococcal Conjugate Vaccine
What is being tested?: 13-valent pneumococcal conjugate vaccine (13vPnC) and 7-valent pneumococcal conjugate vaccine (7vPnC)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 2 sitesTaiwan
Study dates: 5 Jun 2008to 13 Jan 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 98 days
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy 2-month-old infants (42 to 98 days)
Available for the entire study period (14 months)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital - Linko
Taoyuan Hsien, 333

Other trials in Taiwan

About this study

Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN

Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Being tested: 13-valent pneumococcal conjugate vaccine (13vPnC), 7-valent pneumococcal conjugate vaccine (7vPnC)
Keywords: Prevention against pneumococcal disease

What participants receive

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

13-valent pneumococcal conjugate vaccine (13vPnC)Biological
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
7-valent pneumococcal conjugate vaccine (7vPnC)Biological
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Study groups in NCT00688870
Study group	Role	What they receive
1	Experimental	13vPnC Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
2	Active comparator	7vPnC Receives: Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

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 exact 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 19A) are presented.
Measured: 1 month after the infant series (7 months 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 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 19A) are presented.
Measured: 1 month after toddler dose (16 months of age)

Timeline

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

5 Jun 200813 Jan 2010

First posted3 Jun 2008 (estimated)
Study start5 Jun 2008
Primary completion13 Jan 2010
Study completion13 Jan 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VaccinesStudies 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: Double blind
Who is masked: Care provider, Investigator
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00688870
Sponsor's protocol ID: 6096A1-3004
Other IDs: B1851005, 2008-004766-40, 2008
Status last verified: Sep 2022
First submitted: 29 May 2008
Last updated: 7 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.
PubMed 22198517

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN
ClinicalTrials.gov ID: NCT00688870
Acronym / sponsor ID: 6096A1-3004
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Keywords: Prevention against pneumococcal disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: 5 Jun 2008 (actual)
Primary completion: 13 Jan 2010 (actual)
Study completion: 13 Jan 2010 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 12 May 2011

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: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)13vPnC
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)7vPnC

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy 2-month-old infants (42 to 98 days)
Available for the entire study period (14 months)

Key exclusion criteria (2 listed)

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

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 vaccine (13vPnC)13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.	Biological	1
7-valent pneumococcal conjugate vaccine (7vPnC)7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.	Biological	2

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 (7 months of age)
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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 19A) 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 toddler dose (16 months of age)

Results and safety

Results posted to the registry on 12 May 2011, 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	84	80
7vPnC	84	84

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 (7 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC n = 80	7vPnC n = 83
Common Serotypes - Serotype 4	98.8 (93.2 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 6B	100.0 (95.5 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 9V	98.8 (93.2 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 14	100.0 (95.5 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 18C	100.0 (95.5 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 19F	98.8 (93.2 to 100.0)	100.0 (95.7 to 100.0)
Common Serotypes - Serotype 23F	95.0 (87.7 to 98.6)	100.0 (95.7 to 100.0)
Additional Serotypes - Serotype 1	98.8 (93.2 to 100.0)	2.4 (0.3 to 8.4)

13vPnC vs 7vPnC: Difference: -1.2 (95% CI -6.8 to 3.3), Chan and Zhang
13vPnC vs 7vPnC: Difference: 0.0 (95% CI -4.6 to 4.3), Chan and Zhang
13vPnC vs 7vPnC: Difference: -1.2 (95% CI -6.8 to 3.3), Chan and Zhang

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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline through 1 month after last study vaccination (16 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=15 months of age.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infant Series 13vPnC	4 of 83 (4.8%)	81 of 83 (97.6%)	Not reported
Infant Series 7vPnC	4 of 84 (4.8%)	77 of 84 (91.7%)	Not reported
After the Infant Series 13vPnC	12 of 83 (14.5%)	11 of 83 (13.3%)	Not reported
After the Infant Series 7vPnC	9 of 84 (10.7%)	16 of 84 (19%)	Not reported
Toddler Dose 13vPnC	0 of 80 (0%)	39 of 80 (48.8%)	Not reported
Toddler Dose 7vPnC	3 of 84 (3.6%)	47 of 84 (56%)	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 7 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22198517Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

2 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 2 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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 12 May 2011). 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 (7 months of age)). 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 NCT00688870, which also lists 1 linked publication.

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 7 Oct 2022.