Vaccines, Pneumococcal Conjugate VaccinePhase 3NCT00676091

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

A Phase 3 study testing 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) and 7-Valent Pneumococcal Conjugate Vaccine (7vPnc) in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 4 sites in Brazil.

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 will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines. Read more about this study

Who is it for?: Ages 28 to 54 daysHealthy volunteers can take part
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: 354 participants
Where: 4 sitesBrazil
Study dates: Apr 2008to Sep 2009
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 28 to 54 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 1 month old infants
Available for the duration of the study and reachable by telephone
Able to complete two blood drawing procedures during the study

Who cannot join

Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
Bleeding disorder, immune deficiency or significant chronic or congenital disease
Previous receipt of blood products or immune globulin

Trial locations and contacts

4 sites in 1 country.

Brazil4 sites

Study site
Curitiba, 80060-900
Study site
Florianópolis, 88025-301
Study site
Sau Paulo, 04020-060
Study site
Sau Paulo, 04038-001

Other trials in Brazil

About this study

Official title: A Phase 3, 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 Brazil

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Being tested: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
Keywords: Pneumococcal conjugate vaccine

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
7-Valent Pneumococcal Conjugate Vaccine (7vPnc)Biological

Study groups in NCT00676091
Study group	Role	What they receive
13vPnC	Experimental	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Receives: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
7vPnC	Active comparator	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). 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 Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 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)
Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.
Measured: 1 month after the infant series (7 months of age)

Secondary outcomes (2)

Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 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 toddler dose (13 months of age)
Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) 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.

Apr 2008Sep 2009

First posted12 May 2008 (estimated)
Study startApr 2008
Primary completionSep 2009
Study completionSep 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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00676091
Sponsor's protocol ID: 6096A1-012
Status last verified: Aug 2011
First submitted: 8 Apr 2008
Last updated: 8 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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Active, not recruitingObservational study
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RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
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Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
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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 2011. 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 a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Brazil
ClinicalTrials.gov ID: NCT00676091
Acronym / sponsor ID: 6096A1-012
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Keywords: Pneumococcal conjugate vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 354 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 12 May 2008 (estimated)
Results: Posted 15 Oct 2010

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 will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
13vPnC	Experimental	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC	Active comparator	Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Who may qualify

Ages: 28 to 54 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy 1 month old infants
Available for the duration of the study and reachable by telephone
Able to complete two blood drawing procedures during the study

Key exclusion criteria (3 listed)

Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
Bleeding disorder, immune deficiency or significant chronic or congenital disease
Previous receipt of blood products or immune globulin

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)	Biological	13vPnC
7-Valent Pneumococcal Conjugate Vaccine (7vPnc)	Biological	7vPnC

Primary outcome

Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 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% 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.
Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 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 ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.

2 secondary outcomes

Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 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 Oct 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	177	157
7vPnC	177	159

Primary outcome: Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 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 = 156	7vPnC n = 158
Common serotypes - serotype 4	100.0 (97.7 to 100.0)	100.0 (97.7 to 100.0)
Common serotypes - serotype 6B	96.8 (92.7 to 99.0)	95.6 (91.1 to 98.2)
Common serotypes - serotype 9V	98.7 (95.4 to 99.8)	100.0 (97.7 to 100.0)
Common serotypes - serotype 14	98.1 (94.5 to 99.6)	97.5 (93.6 to 99.3)
Common serotypes - serotype 18C	97.4 (93.6 to 99.3)	98.1 (94.5 to 99.6)
Common serotypes - serotype 19F	94.2 (89.3 to 97.3)	98.7 (95.5 to 99.8)
Common serotypes - serotype 23F	96.8 (92.7 to 99.0)	93.0 (87.8 to 96.5)
Additional serotypes - serotype 1	99.4 (96.5 to 100.0)	2.5 (0.7 to 6.4)

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

Primary outcome: Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 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 = 156	7vPnC n = 158
PT ≥5 EU/mL	35.9 (28.4 to 44.0)	32.3 (25.1 to 40.2)
FHA ≥5 EU/mL	70.1 (62.2 to 77.2)	71.5 (63.8 to 78.4)
PRN ≥5 EU/mL	93.5 (88.5 to 96.9)	96.2 (91.9 to 98.6)

Population analysed: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.

2 secondary outcomes are 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	10 of 163 (6.1%)	140 of 163 (85.9%)	Not reported
Infant Series 7vPnC	10 of 162 (6.2%)	140 of 162 (86.4%)	Not reported
After the Infant Series 13vPnC	10 of 163 (6.1%)	18 of 163 (11%)	Not reported
After the Infant Series 7vPnC	5 of 162 (3.1%)	12 of 162 (7.4%)	Not reported
Toddler Dose 13vPnC	2 of 155 (1.3%)	84 of 155 (54.2%)	Not reported
Toddler Dose 7vPnC	3 of 156 (1.9%)	86 of 156 (55.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vaccines, Pneumococcal Conjugate Vaccine

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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

4 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 3 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 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Brazil. 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 Oct 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 Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (time frame: 1 Month after the infant series (7 Months 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 NCT00676091.

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 2011.