Vaccines, PneumococcalPhase 3NCT00366678

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

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine and Pentavac in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 45 sites in France.

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

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France. Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
What is being tested?: 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine and Pentavac
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 613 participants
Where: 45 sitesFrance
Study dates: Oct 2006to Nov 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 42 to 98 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 2-month-old infants.
Available for the entire study period.

Who cannot join

Known contraindication to vaccines.

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

France45 sites

Study site
Albi, 81000
Study site
Amiens, 80000
Study site
Ancenis, 44150
Study site
Blanquefort, 33370
Study site
Bondues, 59910
Study site
Bordeaux, 33000
Study site
Brest, 29200
Study site
Châlons-en-Champagne, 51000
Study site
Créteil, 94000
Study site
Dijon, 21000
Study site
Draguignan, 83300
Study site
Écully, 69130
Study site
Essey-lès-Nancy, 54270
Study site
Floirac, 33270
Study site
Fréjus, 83600
Study site
Garges-lès-Gonesse, 95140
Study site
Illkirch-Graffenstaden, 67400
Study site
Joué-lès-Tours, 37300
Study site
Le Havre, 76600
Study site
Le Plessis-Trévise, 94420
Study site
Le Pontet, 84130
Study site
Les Lilas, 93260
Study site
Les Sables-d'Olonne, 85100
Study site
Libourne, 33500
Study site
Lingolsheim, 67380
Study site
Lyon, 69005
Study site
Lyon, 69007
Study site
Marcq-en-Barœul, 59700
Study site
Maromme, 76150
Study site
Moûtiers, 73600
Study site
Nancy, 54000
Study site
Nice, 06300
Study site
Nogent-sur-Marne, 94130
Study site
Oullins, 69600
Study site
Paris, 75571
Study site
Rouen, 76100
Study site
Strasbourg, 67000
Study site
Strasbourg, 67100
Study site
Thionville, 57100
Study site
Tours, 37000
Study site
Tresses Melac, 33370
Study site
Vandœuvre-lès-Nancy, 54500
Study site
Vaulx-en-Velin, 69120
Study site
Villeneuve-d'Ascq, 59650
Study site
Vitry-sur-Seine, 94400

Other trials in France

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 France.

Conditions: Vaccines, Pneumococcal
Being tested: 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine, Pentavac
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 0.5 mL dose given at 2, 3, 4, and 12 months of age.
7-valent pneumococcal conjugate vaccineBiological
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
PentavacDrug
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Study groups in NCT00366678
Study group	Role	What they receive
13-valent pneumococcal conjugate vaccine	Experimental	13-valent pneumococcal conjugate vaccine Receives: Biological: 13-valent pneumococcal conjugate vaccine; Drug: Pentavac
7-valent pneumococcal conjugate vaccine	Active comparator	7-valent pneumococcal conjugate vaccine Receives: Biological: 7-valent pneumococcal conjugate vaccine; Drug: Pentavac

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, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Measured: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Measured: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
Measured: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Measured: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Measured: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 the 3-Dose Infant Series (at 5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Antibody GMC 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.
Measured: One month after the 3-Dose Infant Series (at 5 months of age)

Secondary outcomes (4)

Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/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 the toddler dose (at 13 months of age)
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after the toddler dose (at 13 months of age)
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after the toddler dose (at 13 months of age)

Timeline

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

Oct 2006Nov 2008

First posted21 Aug 2006 (estimated)
Study startOct 2006
Primary completionNov 2008
Study completionNov 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.
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: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00366678
Sponsor's protocol ID: 6096A1-008
Status last verified: Jul 2012
First submitted: 17 Aug 2006
Last updated: 15 Aug 2012
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
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Vaccines, Pneumococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 15 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 Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.
ClinicalTrials.gov ID: NCT00366678
Acronym / sponsor ID: 6096A1-008
Conditions: Vaccines, Pneumococcal
Keywords: Safety, Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 613 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 21 Aug 2006 (estimated)
Results: Posted 15 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
13-valent pneumococcal conjugate vaccine	Experimental	Biological: 13-valent pneumococcal conjugate vaccine, Drug: Pentavac13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine, Drug: Pentavac7-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.
Available for the entire study period.

Key exclusion criteria (1 listed)

Known contraindication to vaccines.

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 0.5 mL dose given at 2, 3, 4, and 12 months of age.	Biological	13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccineSingle 0.5 mL dose given at 2, 3, 4, and 12 months of age.	Biological	7-valent pneumococcal conjugate vaccine
PentavacThe Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).	Drug	13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine

Primary outcome

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Time frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Time frame: One month after the 3-Dose Infant Series (at 5 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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.
Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: During the 4-day period after each dose
Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events
Time frame: During the 4-day period after each dose
Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Time frame: One month after the 3-Dose Infant Series (at 5 months of age)
Antibody GMC 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.

4 secondary outcomes

Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Time frame: One month after the toddler dose (at 13 months of age)
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Time frame: One month after the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Time frame: One month after the toddler dose (at 13 months of age)
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Time frame: One month after the toddler dose (at 13 months of age)

Results and safety

Results posted to the registry on 15 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/13vPnC Vaccine	304	290
7vPnC/7vPnC Vaccine	309	299
7vPnC/13vPnC Vaccine	0	0

Primary outcome: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group

Time frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC After the Infant Series n = 266	7vPnC After the Infant Series n = 263	13vPnC After the Toddler Dose n = 241	7vPnC After the Toddler Dose n = 133
Pertussis - PT Infant ≥5 Toddler 5 (EU/mL)	100.0 (98.6 to 100.0)	100.0 (98.6 to 100.0)	100.0 (98.5 to 100.0)	100.0 (97.3 to 100.0)
Pertussis - PT Infant ≥26 Toddler 17 (EU/mL)	94.3 (90.8 to 96.8)	95.0 (91.7 to 97.3)	98.3 (95.8 to 99.5)	96.2 (91.4 to 98.8)
Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL)	100.0 (98.6 to 100.0)	100.0 (98.6 to 100.0)	100.0 (98.5 to 100.0)	100.0 (97.3 to 100.0)
Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL)	100.0 (98.6 to 100.0)	100.0 (98.6 to 100.0)	100.0 (98.5 to 100.0)	100.0 (97.3 to 100.0)
Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL)	93.5 (89.9 to 96.2)	95.8 (92.6 to 97.9)	92.5 (88.4 to 95.5)	95.5 (90.4 to 98.3)
Diphtheria 0.1 (IU/mL)	76.5 (70.9 to 81.5)	84.6 (79.6 to 88.7)	99.2 (97.0 to 99.9)	100 (97.3 to 100.0)
Diphtheria 0.01 (IU/mL)	100.0 (98.6 to 100.0)	100.0 (98.6 to 100.0)	100.0 (98.5 to 100.0)	100.0 (97.3 to 100.0)
Tetanus 0.1 (IU/mL)	84.9 (80.0 to 89.1)	82.2 (76.9 to 86.7)	96.2 (93.0 to 98.3)	98.5 (94.7 to 99.8)

13vPnC After the Infant Series vs 7vPnC After the Infant Series: Difference: 0.0 (95% CI -1.4 to 1.4)
13vPnC After the Infant Series vs 7vPnC After the Infant Series: Difference: -0.7 (95% CI -4.8 to 3.3)
13vPnC After the Infant Series vs 7vPnC After the Infant Series: Difference: 0.0 (95% CI -1.4 to 1.4)

Population analysed: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group

Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	13vPnC After the Infant Series n = 266	7vPnC After the Infant Series n = 263	13vPnC After the Toddler Dose n = 241	7vPnC After the Toddler Dose n = 133
Diphtheria	0.19 (0.17 to 0.21)	0.24 (0.22 to 0.27)	2.09 (1.87 to 2.34)	2.60 (2.26 to 2.99)
Tetanus	0.20 (0.18 to 0.22)	0.21 (0.19 to 0.23)	1.08 (0.94 to 1.24)	1.25 (1.05 to 1.47)

13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.77 (95% CI 0.66 to 0.90)
13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.94 (95% CI 0.82 to 1.08)
13vPnC After the Toddler Dose vs 7vPnC After the Toddler Dose: Ratio: 0.80 (95% CI 0.67 to 0.97)

Primary outcome: Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group

Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age). Number (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC After the Infant Series n = 244	7vPnC After the Infant Series n = 241	13vPnC After the Toddler Dose n = 240	7vPnC After the Toddler Dose n = 132
Value	1.28 (1.10 to 1.49)	1.40 (1.19 to 1.64)	12.15 (10.54 to 14.00)	11.68 (9.66 to 14.13)

13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.91 (95% CI 0.73 to 1.14)
13vPnC After the Toddler Dose vs 7vPnC After the Toddler Dose: Ratio: 1.04 (95% CI 0.82 to 1.32)

Population analysed: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group

Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age). Number (95% Confidence Interval). Unit: titer

Measure	13vPnC After the Infant Series n = 258	7vPnC After the Infant Series n = 256	13vPnC After the Toddler Dose n = 239	7vPnC After the Toddler Dose n = 129
Polio Type 1	24.99 (21.37 to 29.23)	28.33 (24.40 to 32.89)	253.05 (207.15 to 309.11)	250.56 (193.17 to 324.99)
Polio Type 2	17.75 (15.07 to 20.92)	21.55 (18.43 to 25.20)	408.34 (338.94 to 491.95)	415.20 (325.57 to 529.52)
Polio Type 3	41.08 (34.08 to 49.52)	52.95 (43.26 to 64.82)	536.32 (436.46 to 659.02)	638.18 (501.50 to 812.13)

13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.88 (95% CI 0.71 to 1.09)
13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.82 (95% CI 0.66 to 1.03)
13vPnC After the Infant Series vs 7vPnC After the Infant Series: Ratio: 0.78 (95% CI 0.59 to 1.02)

Population analysed: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	5 of 304 (1.6%)	142 of 304 (46.7%)	Not reported
7vPnC Infant Series	5 of 309 (1.6%)	162 of 309 (52.4%)	Not reported
13vPnC Post-Infant Series	8 of 290 (2.8%)	12 of 290 (4.1%)	Not reported
7vPnC Post-Infant Series	5 of 299 (1.7%)	11 of 299 (3.7%)	Not reported
13vPnC/13vPnC Toddler Dose	2 of 273 (0.7%)	125 of 272 (46%)	Not reported
7vPnC/7vPnC Toddler Dose	0 of 152 (0%)	64 of 152 (42.1%)	Not reported
7vPnC/ 13vPnC Toddler Dose	2 of 134 (1.5%)	63 of 137 (46%)	Not reported
13vPnC / 13vPnC 6-Month Follow-up	6 of 267 (2.2%)	2 of 267 (0.7%)	Not reported
7vPnC / 7vPnC 6-Month Follow-up	1 of 150 (0.7%)	2 of 150 (1.3%)	Not reported
7vPnC / 13vPnC 6-Month Follow-up	0 of 133 (0%)	2 of 133 (1.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vaccines, Pneumococcal

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
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

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 France, infomedfrance@wyeth.com

45 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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 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 45 sites in France. 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 15 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 Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group (time frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)). The study lists 9 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 NCT00366678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.