Healthy SubjectsPhase 4NCT01250756

A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

A Phase 4 study testing 7-pneumococcal conjugate vaccine (7vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP) and DTaP in people with Healthy Subjects, run by Pfizer at 18 sites in Japan.

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 3 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: 7-pneumococcal conjugate vaccine (7vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP) and DTaP
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 18 sitesJapan
Study dates: Nov 2010to Mar 2012
Phase: Phase 4
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 3 to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
Available for entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Japan18 sites

Tsubaki Children's Clinic
Chiba, Chiba
Kiyomatsu Childrens Clinic
Fukuoka, Fukuoka
National Hospital Organization Fukuoka National Hospital
Fukuoka, Fukuoka
Shindo Children's Clinic
Fukuoka, Fukuoka
Takasaki Clinic Pedatrics and Child Health
Fukuoka, Fukuoka
Sotobo Children's Clinic
Isumi, Chiba
Yamashita Pediatrics Clinic
Itoshima, Fukuoka
Yokoyama Children's Clinic
Kasuga, Fukuoka
Shibuya Clinic
Kumagaya, Saitama
Kawasaki Medical School, Department of Pediatrics
Kurashiki, Okayama-ken
Matsuda Pediatrics Clinic
Kuwana, Mie-ken
Matsuyama Red Cross Hospital
Matsuyama, Ehime
Momotaro Clinic
Okayama, Okayama-ken
Furuta Children's Clinic
Sapporo, Hokkaido
Tenshi Hospital
Sapporo, Hokkaido
Watanabe Pediatric Allergy Clinic
Sapporo, Hokkaido
Yamanaka Tatsuru Pediatrics
Sapporo, Hokkaido
Hug Hug Kids Clinic
Toyonaka, Osaka

Other trials in Japan

About this study

Official title: A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

Conditions: Healthy Subjects
Being tested: 7-pneumococcal conjugate vaccine (7vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), DTaP
Keywords: vaccine, pneumococcal conjugate

What participants receive

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

7-pneumococcal conjugate vaccine (7vPnC)Biological
0.5 mL per dose, 4 doses
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)Biological
0.5 mL per dose, 4 doses
DTaPBiological
0.5 mL per dose, 4 doses

Study groups in NCT01250756
Study group	Role	What they receive
1	Experimental	Experimental Receives: Biological: 7-pneumococcal conjugate vaccine (7vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
2	Experimental	Active comparator Receives: Biological: DTaP

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Measured: 1 month after the infant series
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after the infant series

Secondary outcomes (8)

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Measured: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Measured: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Measured: 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the toddler dose
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after the toddler dose
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Measured: Pre-toddler dose, 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the catch-up dose 3
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after the catch-up dose 3

Timeline

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

Nov 2010Mar 2012

First posted1 Dec 2010 (estimated)
Study startNov 2010
Primary completionMar 2012
Study completionMar 2012

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 Healthy SubjectsStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01250756
Sponsor's protocol ID: B1841007
Other IDs: B1841007, 6107A1-4000
Status last verified: Jan 2013
First submitted: 29 Nov 2010
Last updated: 26 Feb 2013
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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
ClinicalTrials.gov ID: NCT01250756
Acronym / sponsor ID: B1841007
Conditions: Healthy Subjects
Keywords: vaccine, pneumococcal conjugate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 1 Dec 2010 (estimated)
Results: Posted 26 Feb 2013

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: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 7-pneumococcal conjugate vaccine (7vPnC), Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)Experimental
2	Experimental	Biological: DTaPActive comparator

Who may qualify

Ages: 3 to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
Available for entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (5 listed)

Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.

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
7-pneumococcal conjugate vaccine (7vPnC)0.5 mL per dose, 4 doses	Biological	1
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)0.5 mL per dose, 4 doses	Biological	1
DTaP0.5 mL per dose, 4 doses	Biological	2

Primary outcome

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Time frame: 1 month after the infant series
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Time frame: 1 month after the infant series
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Time frame: 1 month after the infant series
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Time frame: 1 month after the infant series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Time frame: 1 month after the infant series
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

8 secondary outcomes

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Time frame: Pre-toddler dose, 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Time frame: 1 month after the catch-up dose 3
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Time frame: 1 month after the catch-up dose 3

Results and safety

Results posted to the registry on 26 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7vPnC + DTaP	161	133
DTaP (Catch-up 7vPnC)	160	153

Primary outcome: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

Time frame: 1 month after the infant series. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	7vPnC + DTaP n = 132	DTaP (Catch-up 7vPnC) n = 149
Diphtheria	100.0 (97.2 to 100.0)	100.0 (97.6 to 100.0)
Tetanus	100.0 (97.2 to 100.0)	100.0 (97.6 to 100.0)
Pertussis toxoid (PT)	100.0 (97.2 to 100.0)	100.0 (97.6 to 100.0)
Filamentous hemagglutinin (FHA)	100.0 (97.2 to 100.0)	100.0 (97.6 to 100.0)

Population analysed: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

Time frame: 1 month after the infant series. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	7vPnC + DTaP n = 132	DTaP (Catch-up 7vPnC) n = 149
Diphtheria	1.38 (1.27 to 1.49)	0.99 (0.91 to 1.09)
Tetanus	1.91 (1.69 to 2.16)	2.05 (1.83 to 2.29)

Primary outcome: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

Time frame: 1 month after the infant series. Geometric mean (95% Confidence Interval). Unit: EU/mL

Measure	7vPnC + DTaP n = 132	DTaP (Catch-up 7vPnC) n = 149
Pertussis toxoid (PT)	76.79 (70.81 to 83.28)	83.56 (77.54 to 90.05)
Filamentous hemagglutinin (FHA)	72.89 (65.80 to 80.74)	77.85 (71.01 to 85.35)

Primary outcome: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series

Time frame: 1 month after the infant series. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	7vPnC + DTaP n = 132
4	100.0 (97.2 to 100.0)
6B	99.2 (95.9 to 100.0)
9V	100.0 (97.2 to 100.0)
14	99.2 (95.9 to 100.0)
18C	99.2 (95.8 to 100.0)
19F	97.7 (93.5 to 99.5)
23F	98.5 (94.6 to 99.8)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7vPnC + DTaP - Infant Series	3 of 159 (1.9%)	123 of 159 (77.4%)	Not reported
DTaP (Catch-up 7vPnC)- Infant Series	7 of 158 (4.4%)	126 of 158 (79.7%)	Not reported
7vPnC + DTaP - After the Infant Series	10 of 159 (6.3%)	20 of 159 (12.6%)	Not reported
DTaP (Catch-up 7vPnC) - After the Infant Series	7 of 158 (4.4%)	129 of 158 (81.6%)	Not reported
7vPnC + DTaP - Toddler Dose	0 of 122 (0%)	72 of 122 (59%)	Not reported
DTaP (Catch-up 7vPnC) - Toddler Dose	4 of 149 (2.7%)	96 of 149 (64.4%)	Not reported
DTaP (Catch-up 7vPnC) - After the Toddler Dose	1 of 149 (0.7%)	85 of 149 (57%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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

18 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 5 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 26 Feb 2013). 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 Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series (time frame: 1 month after the infant series). The study lists 5 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 NCT01250756.

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 26 Feb 2013.