Healthy SubjectsPhase 3NCT01200368

Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP) and 7-valent pneumococcal conjugate vaccine (7vPnC) in people with Healthy Subjects, run by Pfizer at 32 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 to 6 months
Conditions the study is for: Healthy Subjects
What is being tested?: 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP) and 7-valent pneumococcal conjugate vaccine (7vPnC)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 551 participants
Where: 32 sitesJapan
Study dates: 24 Sep 2010to 30 Nov 2011
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 3 to 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female subjects between 3 to 6 months of age at the enrollment.
Available for the entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgement 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).
Infant who is a direct descendant (child, grandchild) of the study site personnel.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

Japan32 sites

Sakiyama Children's Clinic
Fuchū, Tokyo, 183-0042
National Hospital Organization Fukuoka National Hospital
Fukuoka, 811-1394
Harada Clinic
Fukuoka, 816-0094
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, 720-8520
Sunrise Children's Clinic
Funabashi, Chiba, 273-0035
Fukazawa Pediatric Clinic
Higashi-ku, Fukuoka-city, Fukuoka, 813-0036
Sotobo Children's Clinic
Isumi, Chiba, 299-4503
Yoshimoto Pediatrist Clinic
Kikuchi-gun, Kumamoto, 869-1102
Childrens Clinic of Kose
Kofu, Yamanashi, 400-0853
Medical Corporation Bunpoukai Amemiya Clinic
Koushu-shi, Yamanashi, 404-0046
Children's Enomoto Clinic
Kumagaya, Saitama, 360-0018
Shibuya Clinic
Kumagaya, Saitama, 360-0812
Hattori Pediatric Clinic
Kumamoto, 860-0812
Medical Corporation Seiaikai Seguchi Pediatric Clinic
Kumamoto, 860-0834
Medical Corporation Oukakai Sakuranbo Kodomo Clinic
Kumamoto, 862-0924
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790-8524
Momotaro Clinic
Okayama, 701-0205
Okawa Children and Family Clinic
Ōta-ku, Tokyo, 146-0095
Nakata pediatric clinic
Sapporo, Hokkaido, 003-0023
Watanabe Pediatric Allergy Clinic
Sapporo, Hokkaido, 006-0831
Furuta Children's Clinic
Sapporo, Hokkaido, 063-0831
Motomachi pediatric clinic
Sapporo, Hokkaido, 065-0024
Tenshi Hospital
Sapporo, Hokkaido, 065-8611
Seijo Sasamoto Pediatric And Allergy Clinic
Setagaya-ku, Tokyo, 157-0066
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535
Shiroko Clinic
Suzuka, Mie-ken, 510-0235
Miyata Pediatric Clinic
Tachikawa-shi, Tokyo, 190-0002
Maehara Pediatric Clinic
Tama, Tokyo, 206-0011
National Mie Hospital
Tsu, Mie-ken, 514-0125
National hospital Organization Mie Chuou Medical Center
Tsu, Mie-ken, 514-1101
Medical Corporation Seijinkai Takei Clinic
Tsuru-shi, Yamanashi, 402-0025

Other trials in Japan

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 Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants

Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.

Conditions: Healthy Subjects
Being tested: 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), 7-valent pneumococcal conjugate vaccine (7vPnC), DTaP
Keywords: vaccine, pneumococcal conjugate

What participants receive

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

13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL per dose, 4 doses
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)Biological
0.5 mL per dose, 4 doses
7-valent pneumococcal conjugate vaccine (7vPnC)Biological
0.5 mL per dose, 4 doses
DTaPBiological
0.5 mL per dose, 4 doses
DTaPBiological
0.5 mL per dose, 4 doses

Study groups in NCT01200368
Study group	Role	What they receive
1	Experimental	Experimental Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
2	Active comparator	Active comparator Receives: Biological: 7-valent pneumococcal conjugate vaccine (7vPnC); Biological: DTaP
3	Active comparator	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 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% 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 on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (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
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
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

Secondary outcomes (8)

Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Measured: 1 month after the infant series
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 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 on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
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 GMC as measured by mcg/mL 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Measured: 1 month after the toddler dose
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Predefined antibody level was 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 Antibodies 1 Month After the Infant Series
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMC was 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
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Measured: 1 month after the toddler dose

Timeline

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

24 Sep 201030 Nov 2011

First posted13 Sep 2010 (estimated)
Study start24 Sep 2010
Primary completion30 Nov 2011
Study completion30 Nov 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 551 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01200368
Sponsor's protocol ID: B1851056
Other IDs: B1851056, 6096A1-3024
Status last verified: Nov 2018
First submitted: 31 Aug 2010
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.
PubMed 26121200

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 19 Dec 2018. 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 Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants
ClinicalTrials.gov ID: NCT01200368
Acronym / sponsor ID: B1851056
Conditions: Healthy Subjects
Keywords: vaccine, pneumococcal conjugate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 551 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 Sep 2010 (actual)
Primary completion: 30 Nov 2011 (actual)
Study completion: 30 Nov 2011 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 12 Oct 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC), Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)Experimental
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine (7vPnC), Biological: DTaPActive comparator
3	Active comparator	Biological: DTaPActive comparator

Who may qualify

Ages: 3 to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female subjects between 3 to 6 months of age at the enrollment.
Available for the entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgement 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).
Infant who is a direct descendant (child, grandchild) of the study site personnel.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent pneumococcal conjugate vaccine (13vPnC)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
7-valent pneumococcal conjugate vaccine (7vPnC)0.5 mL per dose, 4 doses	Biological	2
DTaP0.5 mL per dose, 4 doses	Biological	2
DTaP0.5 mL per dose, 4 doses	Biological	3

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
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Time frame: 1 month after the infant series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
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
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).

8 secondary outcomes

Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Time frame: 1 month after the infant series
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
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 Antibodies 1 Month After the Infant Series
Time frame: 1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
Time frame: 1 month after the infant series
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

Results and safety

Results posted to the registry on 12 Oct 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 + DTaP	183	180
7vPnC + DTaP	184	178
DTaP (Catch-up 7vPnC)	184	178

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	13vPnC + DTaP n = 177	7vPnC + DTaP n = 176
4	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)
6B	97.7 (94.3 to 99.4)	99.4 (96.9 to 100.0)
9V	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)
14	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)
18C	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)
19F	98.9 (96.0 to 99.9)	96.6 (92.7 to 98.7)
23F	97.7 (94.3 to 99.4)	98.3 (95.1 to 99.6)
1	100.0 (97.9 to 100.0)	96.6 (92.7 to 98.7)

13vPnC + DTaP vs 7vPnC + DTaP: Percent difference: 0.0 (95% CI -2.2 to 2.1)
13vPnC + DTaP vs 7vPnC + DTaP: Percent difference: -1.7 (95% CI -5.2 to 1.1)
13vPnC + DTaP vs 7vPnC + DTaP: Percent difference: 0.0 (95% CI -2.1 to 2.1)

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 and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series

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

Measure	13vPnC + DTaP n = 177	7vPnC + DTaP n = 176
4	9.40 (8.48 to 10.41)	11.54 (10.51 to 12.67)
6B	4.50 (3.90 to 5.21)	5.71 (4.93 to 6.63)
9V	5.04 (4.52 to 5.62)	6.80 (6.15 to 7.52)
14	13.86 (12.16 to 15.80)	16.79 (15.03 to 18.76)
18C	5.30 (4.75 to 5.91)	7.26 (6.53 to 8.08)
19F	7.37 (6.43 to 8.46)	8.38 (7.17 to 9.80)
23F	3.64 (3.16 to 4.19)	4.53 (3.96 to 5.18)

13vPnC + DTaP vs 7vPnC + DTaP: GMC ratio: 0.81 (95% CI 0.71 to 0.94)
13vPnC + DTaP vs 7vPnC + DTaP: GMC ratio: 0.79 (95% CI 0.64 to 0.97)
13vPnC + DTaP vs 7vPnC + DTaP: GMC ratio: 0.74 (95% CI 0.64 to 0.86)

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	13vPnC + DTaP n = 177	7vPnC + DTaP n = 176	DTaP (Catch-up 7vPnC) n = 175
Diphtheria	99.4 (96.9 to 100.0)	96.6 (92.7 to 98.7)	100.0 (97.9 to 100.0)
Tetanus	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)	100.0 (97.9 to 100.0)
Pertussis toxoid (PT)	99.4 (96.9 to 100.0)	96.6 (92.7 to 98.7)	100.0 (97.9 to 100.0)
Filamentous hemagglutinin (FHA)	99.4 (96.9 to 100.0)	96.6 (92.7 to 98.7)	100.0 (97.9 to 100.0)

13vPnC + DTaP vs DTaP (Catch-up 7vPnC): Percent difference: -0.6 (95% CI -3.1 to 1.6)
13vPnC + DTaP vs DTaP (Catch-up 7vPnC): Percent difference: 0.0 (95% CI -2.1 to 2.2)
13vPnC + DTaP vs DTaP (Catch-up 7vPnC): Percent difference: -0.6 (95% CI -3.1 to 1.6)

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 pre-specified 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
13vPnC + DTaP - Infant Series	5 of 183 (2.7%)	147 of 183 (80.3%)	Not reported
7vPnC + DTaP - Infant Series	8 of 183 (4.4%)	160 of 183 (87.4%)	Not reported
DTaP (Catch-up 7vPnC) - Infant Series	10 of 183 (5.5%)	155 of 183 (84.7%)	Not reported
13vPnC + DTaP - After the Infant Series	13 of 183 (7.1%)	20 of 183 (10.9%)	Not reported
7vPnC + DTaP - After the Infant Series	15 of 183 (8.2%)	27 of 183 (14.8%)	Not reported
DTaP (Catch-up 7vPnC) - After the Infant Series	10 of 183 (5.5%)	147 of 183 (80.3%)	Not reported
13vPnC + DTaP - Toddler Dose	0 of 162 (0%)	104 of 162 (64.2%)	Not reported
7vPnC + DTaP - Toddler Dose	4 of 162 (2.5%)	99 of 162 (61.1%)	Not reported
DTaP (Catch-up 7vPnC) - Toddler Dose	2 of 169 (1.2%)	112 of 169 (66.3%)	Not reported
DTaP (Catch-up 7vPnC) - After the Toddler Dose	2 of 169 (1.2%)	105 of 169 (62.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26121200Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.

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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

32 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 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 12 Oct 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 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). 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 NCT01200368, which also lists 1 linked publication.

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 19 Dec 2018.