Pneumococcal InfectionsPhase 3NCT00452452

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Poland.

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) in older infants and children who have not previously been immunized with Pneumococcal vaccine. Read more about this study

Who is it for?: Ages 7 months to 5 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: 13-valent Pneumococcal Conjugate Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 355 participants
Where: 9 sitesPoland
Study dates: Jul 2007to Mar 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 7 months to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged from 7 months to <72 months at time of enrollment.
Available for entire study period and whose parent/legal guardian could be reached by telephone.
Healthy as determined by medical history, physical examination, and judgment of the investigator.
Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal vaccine.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.
History of culture-proven invasive disease caused by S pneumoniae.

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Major known congenital malformation or serious chronic disorders.
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
Child is a direct descendant (child or grandchild) of a member of the study site personnel.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Poland9 sites

Study site
Bydgoszcz, 85-168
Study site
Bydgoszcz, 85-316
Study site
Dębica, 39-200
Study site
Krakow, 31-503
Study site
Łęczna, 21-010
Study site
Lodz, 91-738
Study site
Oborniki Salskie, 55-120
Study site
Proznan, 61-709
Study site
Trzebnica, 55-100

Other trials in Poland

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 Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.

Conditions: Pneumococcal Infections
Being tested: 13-valent Pneumococcal Conjugate Vaccine
Keywords: Pneumococcal Vaccines
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

Study groups in NCT00452452
Study group	Role	What they receive
A	Experimental	Not described Receives: Biological: 13-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 Antibody Level ≥0.35μg/mL After Vaccination
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
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: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).

Secondary outcomes (2)

Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose

Timeline

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

Jul 2007Mar 2008

First posted27 Mar 2007 (estimated)
Study startJul 2007
Primary completionMar 2008
Study completionMar 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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00452452
Sponsor's protocol ID: 6096A1-3002
Status last verified: Jul 2012
First submitted: 23 Mar 2007
Last updated: 15 Aug 2012
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

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
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
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 15 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 Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
ClinicalTrials.gov ID: NCT00452452
Acronym / sponsor ID: 6096A1-3002
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Vaccines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 27 Mar 2007 (estimated)
Results: Posted 15 Aug 2012

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine

Who may qualify

Ages: 7 months to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged from 7 months to <72 months at time of enrollment.
Available for entire study period and whose parent/legal guardian could be reached by telephone.
Healthy as determined by medical history, physical examination, and judgment of the investigator.
Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Key exclusion criteria (11 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal vaccine.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular 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
13-valent Pneumococcal Conjugate Vaccine	Biological	A

Primary outcome

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Time frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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.
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Time frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
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.

2 secondary outcomes

Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Time frame: During the 4-day period after each dose

Results and safety

Results posted to the registry on 15 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 7 to <12 Months of Age	90	88
13vPnC 12 to <24 Months of Age	112	112
13vPnC 24 to < 72 Months of Age	153	152

Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination

Time frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC 7 to <12 Months of Age n = 84	13vPnC 12 to <24 Months of Age n = 110	13vPnC 24 to < 72 Months of Age n = 152
Common Serotypes - Serotype 4 (n= 84,110,151)	100.0 (95.7 to 100.0)	100.0 (96.7 to 100.0)	99.3 (96.4 to 100.0)
Common Serotypes - Serotype 6B (n=83,110,150)	98.8 (93.5 to 100.0)	100.0 (96.7 to 100.0)	99.3 (96.3 to 100.0)
Common Serotypes - Serotype 9V (n= 83,104,148)	98.8 (93.5 to 100.0)	99.0 (94.8 to 100.0)	98.6 (95.2 to 99.8)
Common Serotypes - Serotype 14 (n= 84,108,135)	100.0 (95.7 to 100.0)	100.0 (96.6 to 100.0)	88.1 (81.5 to 93.1)
Common Serotypes - Serotype 18C (n= 83,109,151)	100.0 (95.7 to 100.0)	100.0 (96.7 to 100.0)	98.7 (95.3 to 99.8)
Common Serotypes - Serotype 19F (n=84,110,147)	97.6 (91.7 to 99.7)	100.0 (96.7 to 100.0)	98.0 (94.2 to 99.6)
Common Serotypes - Serotype 23F (n= 84,110,151)	98.8 (93.5 to 100.0)	92.7 (86.2 to 96.8)	93.4 (88.2 to 96.8)
Additional Serotypes - Serotype 1 (n= 83,108,149)	100.0 (95.7 to 100.0)	100.0 (96.6 to 100.0)	96.6 (92.3 to 98.9)

Population analysed: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.

Primary outcome: Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups

Time frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC 7 to <12 Months of Age n = 84	13vPnC 12 to <24 Months of Age n = 110	13vPnC 24 to < 72 Months of Age n = 152
Common Serotypes - Serotype 4	3.63 (3.11 to 4.23)	4.28 (3.78 to 4.86)	3.37 (2.95 to 3.85)
Common Serotypes - Serotype 6B	4.77 (3.90 to 5.84)	3.38 (2.81 to 4.06)	3.41 (2.80 to 4.16)
Common Serotypes - Serotype 9V	2.56 (2.21 to 2.96)	3.08 (2.69 to 3.53)	2.67 (2.32 to 3.07)
Common Serotypes - Serotype 14	8.04 (6.95 to 9.30)	6.45 (5.48 to 7.59)	2.24 (1.71 to 2.93)
Common Serotypes - Serotype 18C	2.77 (2.39 to 3.23)	3.71 (3.29 to 4.19)	2.56 (2.17 to 3.03)
Common Serotypes - Serotype 19F	2.88 (2.35 to 3.54)	3.07 (2.68 to 3.51)	2.53 (2.14 to 2.99)
Common Serotypes - Serotype 23F	2.16 (1.82 to 2.55)	1.98 (1.64 to 2.39)	1.55 (1.31 to 1.85)
Additional Serotypes - Serotype 1	2.88 (2.44 to 3.39)	2.74 (2.37 to 3.16)	1.78 (1.52 to 2.08)

Population analysed: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

2 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 7 to <12 Months of Age	5 of 90 (5.6%)	55 of 90 (61.1%)	Not reported
13vPnC 12 to <24 Months of Age	2 of 112 (1.8%)	77 of 112 (68.8%)	Not reported
13vPnC 24 to < 72 Months of Age	2 of 152 (1.3%)	74 of 152 (48.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumococcal Infections

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
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
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
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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

Trial Manager principal investigator

For Poland: WPWZMED@wyeth.com

9 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 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Poland.

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 4 inclusion and 11 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 15 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 9 sites in Poland. 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 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 ≥0.35μg/mL After Vaccination (time frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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 NCT00452452.

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 15 Aug 2012.