Pneumococcal DiseasePhase 3NCT00743652

Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Disease and 13-valent Pneumococcal Vaccine, run by Pfizer at 21 sites in United States.

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

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children. Read more about this study

Who is it for?: Ages 42 days to 5 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease, 13-valent Pneumococcal Vaccine
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: 373 participants
Where: 21 sitesUnited States
Study dates: Jan 2009to Sep 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 days to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
Infants who have received Prevnar are eligible to participate, but this is not required.
Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Who cannot join

Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Pfizer Investigational Site
Akiak, Alaska, 99552
Pfizer Investigational Site
Bethel, Alaska, 99559
Pfizer Investigational Site
Chefornak, Alaska, 99561
Pfizer Investigational Site
Chevak, Alaska, 99563
Pfizer Investigational Site
Eek, Alaska, 99578
Pfizer Investigational Site
Emmonak, Alaska, 99581
Pfizer Investigational Site
Hooper Bay, Alaska, 99604
Pfizer Investigational Site
Kalskag, Alaska, 99607
Pfizer Investigational Site
Kasigluk, Alaska, 99609
Pfizer Investigational Site
Kongiganak, Alaska, 99545
Pfizer Investigational Site
Kotlik, Alaska, 99620
Pfizer Investigational Site
Kwethluk, Alaska, 99621
Pfizer Investigational Site
Kwigillingok, Alaska, 99622
Pfizer Investigational Site
Mountain Village, Alaska, 99632
Pfizer Investigational Site
Napaskiak, Alaska, 99559
Pfizer Investigational Site
Newtok, Alaska, 99559
Pfizer Investigational Site
Nunapitchuk, Alaska, 99641
Pfizer Investigational Site
Russian Mission, Alaska, 99657
Pfizer Investigational Site
Scammon Bay, Alaska, 99662
Pfizer Investigational Site
Toksook Bay, Alaska, 99637
Pfizer Investigational Site
Tuluksak, Alaska, 99679

Other trials in United States

About this study

Official title: A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Conditions: Pneumococcal Disease, 13-valent Pneumococcal Vaccine
Being tested: 13-valent Pneumococcal Conjugate Vaccine
Keywords: 13 valent Pneumococcal Conjugate Vaccine, Antibody Response, safety, Alaskan Native Children
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
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
13-valent Pneumococcal Conjugate VaccineBiological
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
13-valent Pneumococcal Conjugate VaccineBiological
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
13-valent Pneumococcal Conjugate VaccineBiological
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
13-valent Pneumococcal Conjugate VaccineBiological
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

Study groups in NCT00743652
Study group	Role	What they receive
Group1	Experimental	Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar. Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
Group 2	Experimental	Subjects <12 months of age with 1 prior dose of Prevnar. Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
Group 3	Experimental	Subjects <12 months of age with 2 prior doses of Prevnar. Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
Group 4	Experimental	Subjects ≥12 months to <2 years of age. Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
Group 5	Experimental	Subjects ≥2 years to <5 years of age 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 Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants in 13vPnC Groups 1, 2 and 3 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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.

Secondary outcomes (8)

Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Measured: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Measured: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Measured: Day 1 through Day 7 after vaccination 2 for Group 4
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Measured: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Measured: Day 1 through Day 7 after vaccination 2 for Group 4

Timeline

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

Jan 2009Sep 2010

First posted29 Aug 2008 (estimated)
Study startJan 2009
Primary completionSep 2010
Study completionSep 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.
Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: 373 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00743652
Sponsor's protocol ID: 6096A1-3010
Other IDs: B1851009
Status last verified: Mar 2012
First submitted: 27 Aug 2008
Last updated: 15 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 15 Mar 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, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
ClinicalTrials.gov ID: NCT00743652
Acronym / sponsor ID: 6096A1-3010
Conditions: Pneumococcal Disease, 13-valent Pneumococcal Vaccine
Keywords: 13 valent Pneumococcal Conjugate Vaccine, Antibody Response, safety, Alaskan Native Children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 373 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 29 Aug 2008 (estimated)
Results: Posted 10 Feb 2012

Clinical summary

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

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group1	Experimental	Biological: 13-valent Pneumococcal Conjugate VaccineSubjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
Group 2	Experimental	Biological: 13-valent Pneumococcal Conjugate VaccineSubjects <12 months of age with 1 prior dose of Prevnar.
Group 3	Experimental	Biological: 13-valent Pneumococcal Conjugate VaccineSubjects <12 months of age with 2 prior doses of Prevnar.
Group 4	Experimental	Biological: 13-valent Pneumococcal Conjugate VaccineSubjects ≥12 months to <2 years of age.
Group 5	Experimental	Biological: 13-valent Pneumococcal Conjugate VaccineSubjects ≥2 years to <5 years of age

Who may qualify

Ages: 42 days to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
Infants who have received Prevnar are eligible to participate, but this is not required.
Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Key exclusion criteria (1 listed)

Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.

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 Vaccine4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)	Biological	Group1
13-valent Pneumococcal Conjugate Vaccine3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)	Biological	Group 2
13-valent Pneumococcal Conjugate Vaccine2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)	Biological	Group 3
13-valent Pneumococcal Conjugate Vaccine2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )	Biological	Group 4
13-valent Pneumococcal Conjugate Vaccine1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)	Biological	Group 5

Primary outcome

Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2 and 3 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. Exact 2-sided CI based upon the observed proportion of participants.
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based upon the observed proportion of participants.

8 secondary outcomes

Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Time frame: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Time frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Time frame: Day 1 through Day 7 after vaccination 2 for Group 4
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Time frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Time frame: Day 1 through Day 7 after vaccination 2 for Group 4

Results and safety

Results posted to the registry on 10 Feb 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 Group 1 (3 Doses Infant Series and 1 Toddler Dose)	151	141
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)	51	48
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)	25	23
13vPnC Group 4 (2 Catch-Up Doses)	67	63
13vPnC Group 5 (1 Catch-Up Dose)	79	79

Primary outcome: Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series

Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) n = 11	13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) n = 6	13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) n = 3
Common serotypes - serotype 4	100.0 (71.5 to 100.0)	100.0 (54.1 to 100.0)	100.0 (29.2 to 100.0)
Common serotypes - serotype 6B	100.0 (71.5 to 100.0)	83.3 (35.9 to 99.6)	100.0 (15.8 to 100.0)
Common serotypes - serotype 9V	100.0 (71.5 to 100.0)	83.3 (35.9 to 99.6)	100.0 (29.2 to 100.0)
Common serotypes - serotype 14	90.9 (58.7 to 99.8)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotype - serotype 18C	100.0 (71.5 to 100.0)	100.0 (54.1 to 100.0)	100.0 (29.2 to 100.0)
Common serotype - serotype 19F	100.0 (71.5 to 100.0)	100.0 (54.1 to 100.0)	100.0 (29.2 to 100.0)
Common serotype - serotype 23F	90.9 (58.7 to 99.8)	83.3 (35.9 to 99.6)	100.0 (29.2 to 100.0)
Additional serotype - serotype 1	100.0 (71.5 to 100.0)	100.0 (54.1 to 100.0)	100.0 (29.2 to 100.0)

Population analysed: Evaluable immunogenicity population: received 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 Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose

Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) n = 2	13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) n = 6	13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) n = 2
Common serotypes - serotype 4	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotypes - serotype 6B	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotypes - serotype 9V	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotypes - serotype 14	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotype - serotype 18C	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotype - serotype 19F	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Common serotype - serotype 23F	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)
Additional serotype - serotype 1	100.0 (15.8 to 100.0)	100.0 (54.1 to 100.0)	100.0 (15.8 to 100.0)

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

Primary outcome: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose

Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC Group 4 (2 Catch-Up Doses) n = 4	13vPnC Group 5 (1 Catch-Up Dose) n = 9
Common serotypes - serotype 4	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotypes - serotype 6B	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotypes - serotype 9V	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotypes - serotype 14	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotype - serotype 18C	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotype - serotype 19F	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Common serotype - serotype 23F	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)
Additional serotype - serotype 1	100.0 (39.8 to 100.0)	100.0 (66.4 to 100.0)

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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization to 6 months after last vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Infant Series)	21 of 151 (13.9%)	11 of 151 (7.3%)	Not reported
Group 2 (Infant Series)	2 of 51 (3.9%)	4 of 51 (7.8%)	Not reported
Group 3 (Infant Series)	1 of 25 (4%)	1 of 25 (4%)	Not reported
Group 1 (Toddler Dose)	0 of 15 (0%)	0 of 15 (0%)	Not reported
Group 2 (Toddler Dose)	0 of 23 (0%)	0 of 23 (0%)	Not reported
Group 3 (Toddler Dose)	2 of 16 (12.5%)	0 of 16 (0%)	Not reported
Group 4 (2 Catch-Up Doses)	3 of 66 (4.5%)	1 of 66 (1.5%)	Not reported
Group 5 (1 Catch-Up Dose)	0 of 79 (0%)	0 of 79 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

21 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 Disease and 13-valent Pneumococcal Vaccine, run by Pfizer at 21 sites in United States.

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 1 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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 10 Feb 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 Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series (time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.). The study lists 3 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 NCT00743652.

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 Mar 2012.