Vaccines, Pneumococcal Conjugate VaccinePhase 3NCT00574795

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

A Phase 3 study testing 13vPnC in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 24 sites in Japan.

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 evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent. Read more about this study

Who is it for?: Ages 2 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal Conjugate Vaccine
What is being tested?: 13vPnC
How many people: 193 participants
Where: 24 sitesJapan
Study dates: Sep 2007to Aug 2008
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 2 to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 2 to 6 month-old infant
Available for entire study period

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with a pneumococcal conjugate vaccine.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
Known or suspected immune deficiency or suppression.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Japan24 sites

Study site
Asahikawa-shi, Hokkaido, 078-8211
Study site
Chiba, Chiba, 261-0012
Study site
Fukuoka, Fukuoka, 811-1394
Study site
Fukuoka, Fukuoka, 813-0036
Study site
Fukuoka, Fukuoka, 814-0162
Study site
Fukuoka, Fukuoka, 819-0002
Study site
Ise-shi, Mie-ken, 516-0805
Study site
Kurashiki-shi, Okayama-ken, 701-0192
Study site
Maebaru-shi, Fukuoka, 819-1138
Study site
Matsuyama, Ehime, 790-8524
Study site
Meguro-ku, Tokyo, 152-8902
Study site
Nagoya, Aichi-ken, 466-8650
Study site
Nangoku-shi, Kochi, 783-8505
Study site
Sapporo, Hokkaido, 006-0831
Study site
Sapporo, Hokkaido, 062-0931
Study site
Sapporo, Hokkaido, 063-0831
Study site
Setagaya-ku, Tokyo, 154-0002
Study site
Setagaya-ku, Tokyo, 154-0017
Study site
Setagaya-ku, Tokyo, 157-8535
Study site
Toyohashi, Aichi-ken, 441-8570
Study site
Tsu, Mie-ken, 514-025
Study site
Yokkaichi-shi, Mie-ken, 510-8561
Study site
Yokohama, Kanagawa, 240-8555
Study site
Yokosuka-shi, Kanagawa, 238-8558

Other trials in Japan

About this study

Official title: A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Being tested: 13vPnC

What participants receive

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

13vPnCBiological
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"

What is being measured

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

Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 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: one month after 3-dose infant series (at 7 months of age)

Secondary outcomes (3)

Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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: one mone month after 3-dose infant series (at 7 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 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: one month after the toddler dose (at 12 - 15 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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: one month after the toddler dose (at 12-15 months of age)

Timeline

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

Sep 2007Aug 2008

First posted17 Dec 2007 (estimated)
Study startSep 2007
Primary completionAug 2008
Study completionAug 2008

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 Vaccines, Pneumococcal Conjugate VaccineStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00574795
Sponsor's protocol ID: 6096A1-3003
Status last verified: Jun 2012
First submitted: 13 Dec 2007
Last updated: 8 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.
PubMed 23538524

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

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All Vaccines, Pneumococcal Conjugate Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan
ClinicalTrials.gov ID: NCT00574795
Acronym / sponsor ID: 6096A1-3003
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 17 Dec 2007 (estimated)
Results: Posted 8 Aug 2012

Clinical summary

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

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 2 to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy 2 to 6 month-old infant
Available for entire study period

Key exclusion criteria (5 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with a pneumococcal conjugate vaccine.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
Known or suspected immune deficiency or suppression.

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
13vPnC"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"	Biological	–

Primary outcome

Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Time frame: one month after 3-dose infant series (at 7 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 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.

3 secondary outcomes

Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Time frame: one mone month after 3-dose infant series (at 7 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Time frame: one month after the toddler dose (at 12 - 15 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Time frame: one month after the toddler dose (at 12-15 months of age)

Results and safety

Results posted to the registry on 8 Aug 2012, 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	193	188

Primary outcome: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series

Time frame: one month after 3-dose infant series (at 7 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC After Infant Series n = 176
Common Serotypes - Serotype 4	100.0 (97.9 to 100.0)
Common Serotypes - Serotype 6B	98.3 (95.1 to 99.6)
Common Serotypes - Serotype 9V	100.0 (97.9 to 100.0)
Common Serotypes - Serotype 14	100.0 (97.9 to 100.0)
Common Serotypes - Serotype 18C	100.0 (97.9 to 100.0)
Common Serotypes - Serotype 19F	97.2 (93.5 to 99.1)
Common Serotypes - Serotype 23F	97.7 (94.3 to 99.4)
Additional Serotypes - Serotype 1	100.0 (97.9 to 100.0)

Population analysed: Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	9 of 193 (4.7%)	192 of 193 (99.5%)	Not reported
13vPnC Post-Infant Series	14 of 193 (7.3%)	19 of 193 (9.8%)	Not reported
13vPnC Toddler Dose	1 of 185 (0.5%)	171 of 185 (92.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23538524Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.

Related trials for Vaccines, Pneumococcal Conjugate Vaccine

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
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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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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13vPnC in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 24 sites in Japan.

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 5 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. 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 8 Aug 2012). 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 Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series (time frame: one month after 3-dose infant series (at 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 NCT00574795, 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 8 Aug 2012.