Vaccines, PneumococcalPhase 3NCT00366340

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 51 sites in Germany.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age… Read more about this study

Who is it for?: Ages 56 to 112 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
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: 604 participants
Where: 51 sitesGermany
Study dates: Oct 2006to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 56 to 112 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 2 months (56 to 112 days) at time of enrollment.
Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.

Show all 12Show fewer

History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

Germany51 sites

Study site
Bad Kreuznach, 55543
Study site
Bad Saulgau, 88348
Study site
Bad Sobernheim, 55566
Study site
Berlin, 10551
Study site
Berlin, 10967
Study site
Berlin, 13355
Study site
Berlin, 13409
Study site
Berlin, 13507
Study site
Berlin, 13627
Study site
Birkenfeld, 75217
Study site
Bobingen, 86399
Study site
Bramsche, 49565
Study site
Bretten, 75015
Study site
Cham, 93413
Study site
Ehingen, 89584
Study site
Erlangen, 91056
Study site
Eschwege, 37269
Study site
Flensburg, 24939
Study site
Gau-Odernheim, 55239
Study site
Hamburg, 22763
Study site
Herzogenaurach, 91074
Study site
Höchberg, 97204
Study site
Kehl, 77694
Study site
Kiel, 24111
Study site
Kleve, 47533
Study site
Krefeld, 47798
Study site
Lübeck, 23568
Study site
Ludwigshafen, 67059
Study site
Mainz, 55101
Study site
Metzingen, 72555
Study site
Minden, 32427
Study site
Münster, 48159
Study site
Münster, 48165
Study site
NeumÃ¼nster, 24534
Study site
Neumünster, 24534
Study site
Neustadt/Aisch, 91413
Study site
Niebüll, 25899
Study site
Nuremberg, 90473
Study site
Nuremberg, 90482
Study site
Oberkirch, 77704
Study site
Olching, 82140
Study site
Pforzheim, 75172
Study site
Porta Westfalica, 32457
Study site
Ravensburg, 88214
Study site
Tettnang, 88069
Study site
Vellmar, 34246
Study site
Weiden, 92637
Study site
Weilheim, 82362
Study site
Welzheim, 73642
Study site
Wiesbaden, 65205
Study site
Zirndorf, 90513

Other trials in Germany

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

Conditions: Vaccines, Pneumococcal
Being tested: 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine
Keywords: safety, 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
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
7-valent pneumococcal conjugate vaccineBiological
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Study groups in NCT00366340
Study group	Role	What they receive
1	Experimental	13-valent pneumococcal conjugate vaccine Receives: Biological: 13-valent pneumococcal conjugate vaccine
2	Active comparator	7-valent pneumococcal conjugate vaccine 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 Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after 3-dose infant series (5 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Measured: One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after 3-dose infant series (5 months of age)
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Measured: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Measured: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Measured: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Antibody geometric mean concentration (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.
Measured: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Measured: Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 through 4 after each dose

Timeline

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

Oct 2006Aug 2008

First posted21 Aug 2006 (estimated)
Study startOct 2006
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vaccines, PneumococcalStudies 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: 604 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00366340
Sponsor's protocol ID: 6096A1-006
Status last verified: Jun 2012
First submitted: 17 Aug 2006
Last updated: 8 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.
PubMed 21704105

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

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
ClinicalTrials.gov ID: NCT00366340
Acronym / sponsor ID: 6096A1-006
Conditions: Vaccines, Pneumococcal
Keywords: safety, Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 604 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 21 Aug 2006 (estimated)
Results: Posted 8 Aug 2012

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: 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 vaccine13-valent pneumococcal conjugate vaccine
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine7-valent pneumococcal conjugate vaccine

Who may qualify

Ages: 56 to 112 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged 2 months (56 to 112 days) at time of enrollment.
Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Key exclusion criteria (12 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

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 vaccineSingle 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age	Biological	1
7-valent pneumococcal conjugate vaccineSingle 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age	Biological	2

Primary outcome

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (5 months of age)
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (5 months of age)
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Time frame: One month after 3-dose infant series (5 months of age)
Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (5 months of age)
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Antibody geometric mean concentration (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.
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Time frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.
Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: Day 1 through 4 after each dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Time frame: Day 1 through 4 after each dose
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Time frame: Day 1 through 4 after each dose
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Results and safety

Results posted to the registry on 8 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	301	293
7vPnC	303	293

Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Time frame: One month after 3-dose infant series (5 months of age). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC n = 285	7vPnC n = 279
Common Serotypes-Serotype 4	98.2 (96.0 to 99.4)	98.2 (95.9 to 99.4)
Common Serotypes-Serotype 6B	77.5 (72.2 to 82.2)	87.1 (82.5 to 90.8)
Common Serotypes-Serotype 9V	98.6 (96.4 to 99.6)	96.4 (93.5 to 98.3)
Common Serotypes-Serotype 14	98.9 (96.9 to 99.8)	97.5 (94.9 to 99.0)
Common Serotypes-Serotype 18C	97.2 (94.5 to 98.8)	98.6 (96.3 to 99.6)
Common Serotypes-Serotype 19F	95.8 (92.7 to 97.8)	96.0 (93.0 to 98.0)
Common Serotypes-Serotype 23F	88.7 (84.5 to 92.2)	89.5 (85.3 to 92.9)
Additional Serotypes-Serotype 1	96.1 (93.2 to 98.1)	1.4 (0.4 to 3.7)

13vPnC vs 7vPnC: Difference: 0.0 (95% CI -2.5 to 2.6)
13vPnC vs 7vPnC: Difference: -9.6 (95% CI -16.0 to -3.3)
13vPnC vs 7vPnC: Difference: 2.2 (95% CI -0.4 to 5.2)

Primary outcome: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Time frame: One month after 3-dose infant series (5 months of age). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC n = 285	7vPnC n = 279
Common Serotypes - Serotype 4	2.18 (1.98 to 2.40)	2.99 (2.68 to 3.33)
Common Serotypes - Serotype 6B	0.98 (0.84 to 1.14)	1.49 (1.27 to 1.75)
Common Serotypes - Serotype 9V	1.65 (1.51 to 1.80)	1.96 (1.77 to 2.17)
Common Serotypes - Serotype 14	4.14 (3.68 to 4.66)	4.61 (4.07 to 5.23)
Common Serotypes - Serotype 18C	1.94 (1.76 to 2.14)	2.25 (2.04 to 2.49)
Common Serotypes - Serotype 19F	1.73 (1.56 to 1.92)	2.86 (2.53 to 3.24)
Common Serotypes - Serotype 23F	1.26 (1.11 to 1.43)	1.44 (1.25 to 1.65)
Additional Serotypes - Serotype 1	1.83 (1.64 to 2.04)	0.03 (0.02 to 0.03)

13vPnC vs 7vPnC: Ratio: 0.73 (95% CI 0.63 to 0.84)
13vPnC vs 7vPnC: Ratio: 0.65 (95% CI 0.52 to 0.82)
13vPnC vs 7vPnC: Ratio: 0.84 (95% CI 0.74 to 0.96)

Primary outcome: Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.

Time frame: One month after 3-dose infant series (5 months of age). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC n = 285	7vPnC n = 279
Common Serotypes - Serotype 4 (n=92,94)	100.0 (96.1 to 100.0)	100.0 (96.2 to 100.0)
Common Serotypes - Serotype 6B (n=100,94)	96.0 (90.1 to 98.9)	98.9 (94.2 to 100.0)
Common Serotypes - Serotype 9V (n=89,89)	100.0 (95.9 to 100.0)	100.0 (95.9 to 100.0)
Common Serotypes - Serotype 14 (n=95,89)	100.0 (96.2 to 100.0)	100.0 (95.9 to 100.0)
Common Serotypes - Serotype 18C (n=100,94)	100.0 (96.4 to 100.0)	98.9 (94.2 to 100.0)
Common Serotypes - Serotype 19F (n=100,94)	96.0 (90.1 to 98.9)	93.6 (86.6 to 97.6)
Common Serotypes - Serotype 23F (n=100,93)	96.0 (90.1 to 98.9)	95.7 (89.4 to 98.8)
Additional Serotypes - Serotype 1 (n=100,92)	93.0 (86.1 to 97.1)	4.3 (1.2 to 10.8)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.

Primary outcome: Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Time frame: One month after 3-dose infant series (5 months of age). Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC n = 285	7vPnC n = 279
Common Serotypes -Serotype 4 (n=92,94)	1573.29 (1283.03 to 1929.21)	1860.79 (1540.00 to 2248.41)
Common Serotypes - Serotype 6B (n=100,94)	744.43 (556.91 to 995.11)	1160.76 (921.46 to 1462.19)
Common Serotypes - Serotype 9V (n=89,89)	4937.84 (3614.78 to 6745.14)	5379.51 (3935.51 to 7353.34)
Common Serotypes - Serotype 14 (n=95,89)	2139.65 (1570.10 to 2915.79)	3345.19 (2473.27 to 4524.50)
Common Serotypes - Serotype 18C (n=100,94)	1509.65 (1243.64 to 1832.56)	1780.26 (1382.42 to 2292.59)
Common Serotypes - Serotype 19F (n=100,94)	150.12 (116.89 to 192.81)	165.69 (122.98 to 223.23)
Common Serotypes - Serotype 23F (n=100,93)	1089.92 (795.20 to 1493.86)	1070.83 (786.59 to 1457.78)
Additional Serotypes - Serotype 1 (n=100,92)	50.21 (39.39 to 64.02)	4.15 (3.99 to 4.32)

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

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	12 of 300 (4%)	220 of 299 (73.6%)	Not reported
7vPnC Infant Series	10 of 303 (3.3%)	225 of 300 (75%)	Not reported
13vPnC Post-Infant Series	21 of 300 (7%)	13 of 299 (4.3%)	Not reported
7vPnC Post-Infant Series	23 of 303 (7.6%)	25 of 300 (8.3%)	Not reported
13vPnC Toddler Dose	3 of 300 (1%)	152 of 289 (52.6%)	Not reported
7vPnC Toddler Dose	4 of 303 (1.3%)	143 of 284 (50.4%)	Not reported
13vPnC 6-Month Follow-up	11 of 300 (3.7%)	11 of 287 (3.8%)	Not reported
7vPnC 6-Month Follow-up	14 of 303 (4.6%)	8 of 287 (2.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21704105Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.

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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 Germany, medinfoDEU@wyeth.com

51 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 4 inclusion and 12 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Germany. 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 8 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (time frame: One month after 3-dose infant series (5 months of age)). The study lists 12 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 NCT00366340, 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 8 Aug 2012.