Vaccines, Pneumococcal Conjugate VaccinePhase 3NCT00475033

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine and 7-valent pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 11 sites in Canada.

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

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal Conjugate Vaccine
What is being tested?: 13-valent Pneumococcal Conjugate Vaccine and 7-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 603 participants
Where: 11 sitesCanada
Study dates: Jun 2007to May 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 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 duration of the study and reachable by telephone

Who cannot join

Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
Receipt of blood products or gamma globulin

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Canada11 sites

Study site
Calgary, Alberta, T3B 6A8
Study site
Coquitlam, British Columbia, V3C 4J2
Study site
Edmonton, Alberta, T5N 4A3
Study site
Halifax, Nova Scotia, B3K 6R8
Study site
Montreal, Quebec, H3H 1P3
Study site
Montreal, Quebec, H3T 1C5
Study site
Québec, Quebec, G1E 7G9
Study site
Surrey, British Columbia, V3R 8P8
Study site
Vancouver, British Columbia, V6H 3N1
Study site
Winnipeg, Manitoba, R3A 1M3
Study site
Winnipeg, Manitoba, R3E 0W3

Other trials in Canada

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 Canada

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Being tested: 13-valent Pneumococcal Conjugate Vaccine, 7-valent 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 VaccineBiological
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
7-valent pneumococcal conjugate vaccineBiological
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

Study groups in NCT00475033
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Active comparator	Not described 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 Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Measured: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Measured: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Measured: 1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Measured: 1 month after the 3-dose Infant Series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Measured: 1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Measured: 1 month after the 3-dose infant series (7 months of age)

Secondary outcomes (3)

Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Measured: 1 month after the toddler dose of NeisVac-C® (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Measured: 1 month after the toddler dose (13 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Measured: 1 month after the 3-dose infant series (7 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 2007May 2009

First posted17 May 2007 (estimated)
Study startJun 2007
Primary completionMay 2009
Study completionMay 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 603 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00475033
Sponsor's protocol ID: 6096A1-3008
Status last verified: Apr 2011
First submitted: 15 May 2007
Last updated: 21 Apr 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
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
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

All Vaccines, Pneumococcal Conjugate Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 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 Canada
ClinicalTrials.gov ID: NCT00475033
Acronym / sponsor ID: 6096A1-3008
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 603 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 4 Jun 2010

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine

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 duration of the study and reachable by telephone

Key exclusion criteria (4 listed)

Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
Receipt of blood products or gamma 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 Vaccine13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.	Biological	1
7-valent pneumococcal conjugate vaccine7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.	Biological	2

Primary outcome

Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Time frame: 1 month after the 3-dose infant series (7 months of age)
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Time frame: 1 month after the 3-dose Infant Series (7 months of age)
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Time frame: 1 month after the 3-dose infant series (7 months of age)
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Time frame: 1 month after the 3-dose infant series (7 months of age)
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.

3 secondary outcomes

Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®
Time frame: 1 month after the toddler dose of NeisVac-C® (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Time frame: 1 month after the 3-dose infant series (7 months of age)

Results and safety

Results posted to the registry on 4 Jun 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	300	293
7vPnC	303	290

Primary outcome: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series

Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	13vPnC n = 284	7vPnC n = 278
Value	96.8 (94.1 to 98.5)	99.3 (97.4 to 99.9)

13vPnC vs 7vPnC: Difference: -2.4 (95% CI -5.3 to -0.1)

Population analysed: Evaluable immunogenicity population: had 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 analyzed with a determinate post-infant series antibody concentration to the given antigen.

Primary outcome: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series

Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age). Geometric mean (95% Confidence Interval). Unit: GMT

Measure	13vPnC n = 284	7vPnC n = 278
Value	361.16 (305.46 to 427.00)	302.55 (263.89 to 346.86)

13vPnC vs 7vPnC: Ratio of geometric means: 1.19 (95% CI 0.96 to 1.48)

Population analysed: The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Primary outcome: Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Time frame: 1 month after the 3-dose infant series (7 months of age). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	13vPnC n = 300	7vPnC n = 303
PT ≥5 EU/mL (n=282, 277)	99.6 (98.0 to 100.0)	99.6 (98.0 to 100.0)
FHA ≥5 EU/mL (n=283, 278)	100.0 (98.7 to 100.0)	100.0 (98.7 to 100.0)
PRN ≥5 EU/mL (n=283, 277)	97.9 (95.4 to 99.2)	96.8 (93.9 to 98.5)
FIM ≥2.2 EU/mL (n=282, 275)	95.4 (92.2 to 97.5)	97.5 (94.8 to 99.0)

13vPnC vs 7vPnC: Difference: 0.0 (95% CI -1.6 to 1.7)
13vPnC vs 7vPnC: Difference: 0.0 (95% CI -1.3 to 1.3)
13vPnC vs 7vPnC: Difference: 1.1 (95% CI -1.7 to 4.2)

Population analysed: The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.

Primary outcome: Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Time frame: 1 month after the 3-dose Infant Series (7 months of age). Geometric mean (95% Confidence Interval). Unit: GMC EU/mL

Measure	13vPnC n = 300	7vPnC n = 303
PT (n=282, 277)	46.06 (42.83 to 49.53)	40.37 (37.24 to 43.75)
FHA (n=283,278)	78.08 (72.47 to 84.13)	69.52 (64.39 to 75.05)
PRN (n=283, 277)	42.90 (38.17 to 48.22)	40.69 (36.16 to 45.79)
FIM (n=282, 275)	11.54 (10.48 to 12.71)	12.98 (11.81 to 14.27)

13vPnC vs 7vPnC: Ratio of geometric means: 1.14 (95% CI 1.02 to 1.27)
13vPnC vs 7vPnC: Ratio of geometric means: 1.12 (95% CI 1.01 to 1.25)
13vPnC vs 7vPnC: Ratio of geometric means: 1.05 (95% CI 0.89 to 1.24)

Population analysed: The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	5 of 300 (1.7%)	273 of 300 (91%)	Not reported
7vPnC Infant Series	5 of 303 (1.7%)	279 of 303 (92.1%)	Not reported
13vPnC After the Infant Series	11 of 299 (3.7%)	20 of 299 (6.7%)	Not reported
7vPnC After the Infant Series	7 of 301 (2.3%)	16 of 301 (5.3%)	Not reported
13vPnC Toddler Dose	2 of 286 (0.7%)	199 of 286 (69.6%)	Not reported
7vPnC Toddler Dose	2 of 280 (0.7%)	193 of 280 (68.9%)	Not reported
13vPnC Toddler Dose 6-Month Follow-up	7 of 299 (2.3%)	6 of 299 (2%)	Not reported
7vPnC Toddler Dose 6-Month Follow-up	3 of 301 (1%)	4 of 301 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Canada, clintrialparticipation@wyeth.com

11 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 4 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 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. 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 4 Jun 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 Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series (time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)). The study lists 6 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 NCT00475033.

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 21 Apr 2011.