Pneumococcal VaccinePhase 2NCT00689351

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

A Phase 2 study testing 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites in South Korea.

Completed

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

Official record

Search all trials

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 Korea. Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccine
What is being tested?: 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 6 sitesSouth Korea
Study dates: Jun 2008to Dec 2009
Phase: Phase 2
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
Healthy volunteers accepted
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 vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
A previous severe reaction to any vaccine or vaccine-related component

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

South Korea6 sites

Pfizer Investigational Site
Incheon, Bupyeong-gu, 400-711
Pfizer Investigational Site
Incheon, Jung-gu, 400-711
Pfizer Investigational Site
Kyunggi, Koyang, 412-270
Pfizer Investigational Site
Seoul, Jongno-gu, 110-744
Pfizer Investigational Site
Seoul, Seodaemun-gu, 120-752
Pfizer Investigational Site
Seoul, Yeongdeungpo-gu, 150-950

Other trials in South Korea

About this study

Official title: Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea

Conditions: Pneumococcal Vaccine
Being tested: 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine
Keywords: Prevention, against, pneumococcal, disease, Vaccine
Medical subject headings: Disease

What participants receive

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

13-valent pneumococcal conjugate vaccineBiological
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
7-valent pneumococcal conjugate vaccineBiological
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

Study groups in NCT00689351
Study group	Role	What they receive
1	Experimental	13vPnC Receives: Biological: 13-valent pneumococcal conjugate vaccine
2	Active comparator	7vPnC 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 Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).
Measured: 1 month after the infant series (7 months of age)

Secondary outcomes (1)

Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.
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 2008Dec 2009

First posted3 Jun 2008 (estimated)
Study startJun 2008
Primary completionDec 2009
Study completionDec 2009

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 Pneumococcal 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689351
Sponsor's protocol ID: 6096A1-010
Other IDs: B1851001
Status last verified: Jun 2011
First submitted: 29 May 2008
Last updated: 28 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.
PubMed 23011012

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 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion

All Pneumococcal Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea
ClinicalTrials.gov ID: NCT00689351
Acronym / sponsor ID: 6096A1-010
Conditions: Pneumococcal Vaccine
Keywords: Prevention, against, pneumococcal, disease, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 11 Jan 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 vaccine13vPnC
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine7vPnC

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: 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 vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
A previous severe 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 vaccine13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.	Biological	1
7-valent pneumococcal conjugate vaccine7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.	Biological	2

Primary outcome

Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).

1 secondary outcome

Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 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 11 Jan 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	91	85
7vPnC	89	88

Primary outcome: Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 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 = 91	7vPnC n = 89
Serotype 4	100.0 (95.7 to 100.0)	100.0 (95.8 to 100.0)
Serotype 6B	98.8 (93.5 to 100.0)	100.0 (95.8 to 100.0)
Serotype 9V	100.0 (95.7 to 100.0)	100.0 (95.8 to 100.0)
Serotype 14	100.0 (95.7 to 100.0)	100.0 (95.7 to 100.0)
Serotype 18C	100.0 (95.7 to 100.0)	100.0 (95.8 to 100.0)
Serotype 19F	97.6 (91.6 to 99.7)	98.8 (93.6 to 100.0)
Serotype 23F	98.8 (93.5 to 100.0)	98.8 (93.6 to 100.0)
Serotype 1	100.0 (95.7 to 100.0)	2.4 (0.3 to 8.2)

Population analysed: Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.

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=2 months of age; Dose 2=4 months of age; Dose 3=6 months 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 88 (9.1%)	78 of 88 (88.6%)	Not reported
Infant Series 7vPnC	9 of 89 (10.1%)	75 of 89 (84.3%)	Not reported
After the Infant Series 13vPnC	9 of 88 (10.2%)	18 of 88 (20.5%)	Not reported
After the Infant Series 7vPnC	12 of 89 (13.5%)	19 of 89 (21.3%)	Not reported
Toddler Dose 13vPnC	3 of 84 (3.6%)	28 of 84 (33.3%)	Not reported
Toddler Dose 7vPnC	3 of 88 (3.4%)	36 of 88 (40.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23011012Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Pneumococcal Vaccine

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
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion

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

6 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Jan 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 Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 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 NCT00689351, 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 28 Jun 2011.