DiphtheriaPhase 3NCT01444781

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

A Phase 3 study testing DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide and DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.

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

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose To describe the safety and immunogenicity of… Read more about this study

Who is it for?: Ages 12 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Whooping Cough
What is being tested?: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide and DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,106 participants
Where: 2 sitesin 2 countries
Study dates: Sep 2011to Oct 2013
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 12 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 12 to 24 months on the day of inclusion.
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations).
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with Prevenar™ and Rotarix™).

Who cannot join

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations.
Planned participation in another clinical trial during the present trial period.
Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.
Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine.
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.

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Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian.
History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically.
At high risk for opportunistic infection during the trial.
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
History of contraindication to receipt of pertussis-containing vaccine.
Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating Intramuscular vaccination.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
History of seizures .
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw
Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Colombia1 site

Study site
Cali

Other trials in Colombia

Costa Rica1 site

Study site
San José

Other trials in Costa Rica

About this study

Official title: Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Read the detailed description

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

Conditions: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis
Being tested: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
Keywords: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Pediatric combined vaccine, Invasive Hib infections
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis

What participants receive

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

DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharideBiological
Also called DTaP-IPV-Hep B-PRP~T vaccine, Prevenar™
0.5 mL, Intramuscular each into the right and left deltoid muscle
DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharideBiological
Also called Infanrix hexa™, Prevenar™
0.5 mL, Intramuscular each into the right and left deltoid muscle
DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccineBiological
Also called DTaP-IPV-Hep B-PRP~T combined vaccine, Prevenar™
0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Study groups in NCT01444781
Study group	Role	What they receive
Study Group 1	Experimental	Participants previously primed with DTaP-IPV-Hep B-PRP~T, will receive one dose of DTaP-IPV-Hep B-PRP~T vaccine + one dose of Prevenar™ Receives: Biological: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide
Study Group 2	Active comparator	Participants previously primed with DTaP-IPV-Hep B-PRP~T, will receive one dose of Infanrix hexa™ vaccine + one dose of Prevenar™ Receives: Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide
Study Group 3	Experimental	Participants previously primed with Infanrix hexa™ will receive one dose of DTaP-IPV-Hep B-PRP~T + one dose of Prevenar™. Receives: Biological: DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine

What is being measured

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

Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine
Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
Measured: Day 140 (Primary series) and Day 0 (Pre-booster)
Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Measured: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Measured: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Measured: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination

Secondary outcomes (7)

Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Measured: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.
Measured: Day 30 after final booster vaccination
Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.
Measured: Day 30 after final booster vaccination
Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata
Anti-PT and anti-FHA antibodies were measured by ELISA.
Measured: Day 0 (pre-vaccination) and Day 30 after final booster vaccination
Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
Measured: Day 30 after final booster vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.
Measured: Day 0 up to Day 7 after final booster vaccination
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine
Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.
Measured: Day 0 up to Day 7 after final booster vaccination

Timeline

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

Sep 2011Oct 2013

First posted3 Oct 2011 (estimated)
Study startSep 2011
Primary completionApr 2013
Study completionOct 2013

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 DiphtheriaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444781
Sponsor's protocol ID: A3L27
Other IDs: U1111-1112-8473
Status last verified: Jul 2014
First submitted: 29 Sep 2011
Last updated: 16 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants
ClinicalTrials.gov ID: NCT01444781
Acronym / sponsor ID: A3L27
Conditions: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis
Keywords: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Pediatric combined vaccine, Invasive Hib infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,106 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Apr 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 3 Oct 2011 (estimated)
Results: Posted 16 Jul 2014

Clinical summary

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

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Detailed description

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Study Group 1	Experimental	Biological: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharideParticipants previously primed with DTaP-IPV-Hep B-PRP~T, will receive one dose of DTaP-IPV-Hep B-PRP~T vaccine + one dose of Prevenar™
Study Group 2	Active comparator	Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharideParticipants previously primed with DTaP-IPV-Hep B-PRP~T, will receive one dose of Infanrix hexa™ vaccine + one dose of Prevenar™
Study Group 3	Experimental	Biological: DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccineParticipants previously primed with Infanrix hexa™ will receive one dose of DTaP-IPV-Hep B-PRP~T + one dose of Prevenar™.

Who may qualify

Ages: 12 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged 12 to 24 months on the day of inclusion.
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations).
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with Prevenar™ and Rotarix™).

Key exclusion criteria (18 listed)

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations.
Planned participation in another clinical trial during the present trial period.
Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.
Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine.

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
DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharideAlso: DTaP-IPV-Hep B-PRP~T vaccine, Prevenar™0.5 mL, Intramuscular each into the right and left deltoid muscle	Biological	Study Group 1
DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharideAlso: Infanrix hexa™, Prevenar™0.5 mL, Intramuscular each into the right and left deltoid muscle	Biological	Study Group 2
DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccineAlso: DTaP-IPV-Hep B-PRP~T combined vaccine, Prevenar™0.5 mL (each), Intramuscular each into the right and left deltoid muscle	Biological	Study Group 3

Primary outcome

Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 140 (Primary series) and Day 0 (Pre-booster)
Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

7 secondary outcomes

Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.
Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 30 after final booster vaccination
Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 30 after final booster vaccination
Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata
Time frame: Day 0 (pre-vaccination) and Day 30 after final booster vaccination
Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata
Time frame: Day 30 after final booster vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Time frame: Day 0 up to Day 7 after final booster vaccination
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine
Time frame: Day 0 up to Day 7 after final booster vaccination

Results and safety

Results posted to the registry on 16 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster	416	413
Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster	415	411
Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster	275	272

Primary outcome: Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine

Time frame: Day 140 (Primary series) and Day 0 (Pre-booster). Number. Unit: Participants

Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n = 396	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n = 393	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n = 260
Anti-Diphtheria Day140 ≥0.01 IU/mL (N=392,391,259)	392	391 (0 to 0)	259 (0 to 0)
Anti-Diphtheria Day 140 ≥0.1 IU/mL (N=392,391,259)	308	290 (0 to 0)	197 (0 to 0)
Anti-Diphtheria Day 0 ≥0.01 IU/mL (N=390,390,257)	382	378 (0 to 0)	246 (0 to 0)
Anti-Diphtheria Day 0 ≥0.1 IU/mL (N=390,390,257)	156	153 (0 to 0)	70 (0 to 0)
Anti-Diphtheria Day 30 ≥0.01 IU/mL (N=393,387,254)	393	387 (0 to 0)	254 (0 to 0)
Anti-Diphtheria Day 30 ≥0.1 IU/mL (N=393,387,254)	393	386 (0 to 0)	254 (0 to 0)
Anti-Tetanus Day 140 ≥0.01 IU/mL (N=392,391,258)	392	391 (0 to 0)	258 (0 to 0)
Anti-Tetanus Day 140 ≥0.1 IU/mL (N=392,391,258)	392	390 (0 to 0)	258 (0 to 0)

Population analysed: Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.

Primary outcome: Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination. Number. Unit: Participants

Measure	Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster n = 396	Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster n = 393	Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster n = 260
Anti-PT Day 140 ≥2 EU/mL (N=393,391,259)	393	391 (0 to 0)	259 (0 to 0)
Anti-PT Day 0 ≥2 EU/mL (N=385,382,257)	344	349 (0 to 0)	225 (0 to 0)
A-PT Day 30 ≥ 2 EU/mL (N=391,383,254)	391	383 (0 to 0)	254 (0 to 0)
Anti-PT 4-fold increase (N=380,374,252)	353	351 (0 to 0)	234 (0 to 0)
Anti-PT booster response (N=380,374,252)	375	365 (0 to 0)	245 (0 to 0)
Anti-FHA Day 140 ≥2 EU/mL (N=391,390,259)	391	390 (0 to 0)	259 (0 to 0)
Anti-FHA Day 0 ≥2 EU/mL (N=389,384,255)	389	384 (0 to 0)	253 (0 to 0)
Anti-FHA Day 30 ≥2 EU/mL (N=390,385,254)	390	385 (0 to 0)	254 (0 to 0)

Population analysed: Antibody responses were assessed in the Per-protocol Analysis Set.

Primary outcome: Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination. Number. Unit: Participants

Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n = 396	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n = 393	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n = 260
Anti-Polio 1 Day 140 (N = 338,329,214)	338	329 (0 to 0)	214 (0 to 0)
Anti-Polio 1 Day 0 (N = 338,326,213)	334	320 (0 to 0)	210 (0 to 0)
Anti-Polio 1 Day 30 (N = 339,327,212)	339	327 (0 to 0)	212 (0 to 0)
Anti-Polio 2 Day 140 (N = 338,327,214)	338	327 (0 to 0)	214 (0 to 0)
Anti-Polio 2 Day 0(N = 337,328,213)	335	328 (0 to 0)	213 (0 to 0)
Anti-Polio 2 Day 30 (N = 340,327,212)	340	327 (0 to 0)	212 (0 to 0)
Anti-Polio 3 Day 140 (N = 338,328,214)	338	328 (0 to 0)	214 (0 to 0)
Anti-Polio 3 Day 0 (N = 338,326,213)	324	309 (0 to 0)	211 (0 to 0)

Population analysed: Antibody responses were assessed in the Per Protocol Analysis Set.

Primary outcome: Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination. Number. Unit: Participants

Measure	Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster n = 396	Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster n = 393	Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster n = 260
Anti-Hep B Day 140 ≥10 mIU/mL (N = 393,392,260)	391	391 (0 to 0)	260 (0 to 0)
Anti-Hep B Day 140 ≥100 mIU/mL (N = 393,392,260)	389	387 (0 to 0)	259 (0 to 0)
Anti-Hep B Day 0 ≥10 mIU/mL (N = 396,391,259)	386	382 (0 to 0)	257 (0 to 0)
Anti-Hep B Day 0 ≥100 mIU/mL (N = 396,391,259)	327	333 (0 to 0)	213 (0 to 0)
Anti-Hep B Day 30 ≥10 mIU/mL (N = 395,393,259)	394	391 (0 to 0)	259 (0 to 0)
Anti-Hep B Day 30 ≥100 mIU/mL (N = 395,393,259)	386	384 (0 to 0)	257 (0 to 0)
Anti-PRP Day 140 ≥0.15 µg/mL (N = 393,392,260)	370	375 (0 to 0)	246 (0 to 0)
Anti-PRP Day 140 ≥1.0 µg/mL (N = 393,392,260)	297	305 (0 to 0)	188 (0 to 0)

Population analysed: Antibody responses were assessed in the Per Protocol Analysis Set.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster	13 of 416 (3.1%)	253 of 416 (60.8%)	Not reported
Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster	15 of 415 (3.6%)	221 of 415 (53.3%)	Not reported
Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster	9 of 275 (3.3%)	168 of 275 (61.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur SA

2 sites in 2 countries: 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 18 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia, Costa Rica. 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 16 Jul 2014). 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?

Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine (time frame: Day 140 (Primary series) and Day 0 (Pre-booster)). The study lists 4 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 NCT01444781.

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 16 Jul 2014.