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PoliomyelitisPhase 3NCT00352963

Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

A Phase 3 study of Poliomyelitis and Tetanus, run by GlaxoSmithKline at 22 sites in Spain.

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 study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life. Read more about this study

Who is it for?
Ages Up to 7 daysHealthy volunteers can take part
Conditions the study is for
Poliomyelitis, Tetanus, Acellular Pertussis
Type of treatment
Vaccines
How many people
480 participants
Where
22 sitesSpain
Study dates
30 Sep 2003to 16 Jul 2004
Phase
Phase 3
Are there results?
None posted in the registry

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 Up to 7 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 \& 42 weeks).
  • Written informed consent obtained from the parent/guardian of the subject.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
  • Administration of immunosuppressants or other immune-modifying drugs from birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Spain22 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Almeira, 4009

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08950

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Burgos, 09005

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Getafe, 28905

  • GSK Investigational Site

    Leganés

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Móstoles/Madrid, 28935

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valladolid, 47010

  • GSK Investigational Site

    Vélez-Málaga

Other trials in Spain

About this study

Official title: Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Being tested
Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
Keywords
Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered
Medical subject headings
Poliomyelitis, Tetanus, Hepatitis B, Diphtheria

What participants receive

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

  • Study vaccines: IH+Hib-MenC/NVC; Control: IH+MeningitecBiological

What is being measured

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

  1. At M7: Antibodies to PRP, MenC HBsAg

Secondary outcomes (3)

  1. At M7: Abs. to all vaccine antigens

  2. At M6: Abs. to PRP & MenC

  3. Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

Timeline

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

  1. First posted17 Jul 2006 (estimated)
  2. Study start30 Sep 2003
  3. Study completion16 Jul 2004

Resources

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
None (open label)
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352963
Sponsor's protocol ID
217744/097
Status last verified
Jan 2020
First submitted
14 Jul 2006
Last updated
6 Jan 2020
Results posted
No
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Jacquet JM, Collard A, Schuerman L; Spanish DTaP-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B vaccine coadministered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Aug;25(8):713-20. doi: 10.1097/01.inf.0000227725.61495.c4.

    PubMed 16874171

  • Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-Del-Ri M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Collard A, Boutriau D, Schuerman L, Jacquet JM; Spanish DTPa-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months. Pediatr Infect Dis J. 2007 Jan;26(1):1-7. doi: 10.1097/01.inf.0000247070.60063.09.

    PubMed 17195697

  • Jeanne Jaquet et al. Co-administration of DTPa-HBV-IPV/Hib with two doses of a MenC-TT conjugate vaccine in primary vaccination - 23rd Annual Meeting ESPID, Valencia, Spain, 18-20 May 2005.

  • Tejedor et al. Immunogenicity and reactogenicity of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C-tetanus toxoid conjugate (Hib-MenC-TT) Vaccine co-administered with a pentavalent DTPa-HBV-IPV vaccine at 2, 4 and 6 months - 24th Annual Meeting ESPID, Basel, Switzerland, 03-05 May 2006.

  • Tozzi AE, Azzari C, Bartolozzi G, Esposito S, Fara GM, Giudice ML. Can hexavalent vaccines be simultaneously administered with pneumococcal or meningococcal conjugate vaccines? Hum Vaccin. 2007 Nov-Dec;3(6):252-9. doi: 10.4161/hv.4626. Epub 2007 Jun 23.

    PubMed 17881905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Poliomyelitis and Tetanus, run by GlaxoSmithKline at 22 sites in Spain.

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 6 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

At M7: Antibodies to PRP, MenC HBsAg. 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 NCT00352963, which also lists 5 linked publications.

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 6 Jan 2020.

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