Haemophilus Influenzae Type bPhase 3NCT00322335

Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

A Phase 3 study testing Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta and Infanrix™ hexa in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 12 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 protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). Read more about this study

Who is it for?: Ages 31 to 33 monthsHealthy volunteers can take part
Conditions the study is for: Haemophilus Influenzae Type b, Neisseria Meningitidis
What is being tested?: Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta and Infanrix™ hexa
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 12 sitesSpain
Study dates: May 2006to Sep 2010
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 31 to 33 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

Who cannot join

Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
History of H. influenzae type b, meningococcal serogroup C diseases.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Spain12 sites

GSK Investigational Site
Almería, 04009
GSK Investigational Site
Burgos, 09005
GSK Investigational Site
Getafe/Madrid, 28905
GSK Investigational Site
Girona, 17002
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Málaga, 29011
GSK Investigational Site
Marid, 28040
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Valladolid, 47010
GSK Investigational Site
Vélez-Málaga / Málaga, 29700

Other trials in Spain

About this study

Official title: Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Read the detailed description

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Conditions: Haemophilus Influenzae Type b, Neisseria Meningitidis
Being tested: Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta, Infanrix™ hexa, Engerix-B, NeisVac-C™
Keywords: H.influenzae type b Disease
Medical subject headings: Haemophilus Infections

What participants receive

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

Haemophilus influenzae type b- and meningococcal (vaccine)Biological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
Infanrix™ pentaBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Infanrix™ hexaBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
Engerix-BBiological
Intramuscular injection into the thigh as a birth dose
NeisVac-C™Biological
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
Infanrix™ IPV/HIBBiological
Intramuscular injection into the thigh as primary vaccination at 4 months of age
Meningitec™Biological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Study groups in NCT00322335
Study group	Role	What they receive
Menitorix/Pediarix Group	Experimental	Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. Receives: Biological: Haemophilus influenzae type b- and meningococcal (vaccine); Biological: Infanrix™ penta
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Active comparator	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. Receives: Biological: Haemophilus influenzae type b- and meningococcal (vaccine); Biological: Infanrix™ hexa; Biological: Engerix-B; Biological: NeisVac-C™; Biological: Infanrix™ IPV/HIB
Infanrix hexa/Meningitec Group	Active comparator	Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study. Receives: Biological: Infanrix™ hexa; Biological: Meningitec™

What is being measured

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

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
The cut-off value for the rSBA-MenC titers was equal to or above 1:8.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
The cut-off value for the rSBA-MenC titers was equal to or above 1:32.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
The cut-off value for the rSBA-MenC titers was equal to or above 1:128.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after booster dose (day 0)
rSBA-MenC Titers
Titers are expressed as Geometric Mean Titers (GMTs).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PRP Concentrations
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PSC Concentrations
Concentrations for anti-PSC antibody were expressed as GMCs.
Measured: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Serious Adverse Events
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)

Timeline

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

May 2006Sep 2010

First posted5 May 2006 (estimated)
Study startMay 2006
Primary completionJul 2006
Study completionSep 2010

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 (4)Papers the sponsor has linked to this study.
Other trials for Haemophilus Influenzae Type bStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322335
Sponsor's protocol ID: 106672
Other IDs: 106673, 106675, 106679, 106680
Status last verified: Sep 2016
First submitted: 4 May 2006
Last updated: 20 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Tejedor JC, Moro M, Merino JM, Gomez-Campdera JA, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Ruiz-Contreras J, Martin-Ancel A, Roca J, Boceta R, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 102547 Study Group. Immunogenicity and reactogenicity of a booster dose of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine given to toddlers of 13-14 months of age with antibody persistence up to 31 months of age. Pediatr Infect Dis J. 2008 Jul;27(7):579-88. doi: 10.1097/INF.0b013e31816b4561.
PubMed 18536619
Tejedor JC, Merino JM, Moro M, Navarro ML, Espin J, Omenaca F, Garcia-Sicilia J, Moreno-Perez D, Ruiz-Contreras J, Centeno F, Barrio F, Cabanillas L, Muro M, Esporrin C, De Torres MJ, Caubet M, Boutriau D, Miller JM, Mesaros N. Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2012 Oct;31(10):1074-7. doi: 10.1097/INF.0b013e318269433a.
PubMed 22828645
Tejedor JC et al. Antibody persistence 54 months after a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus-toxoid (HibMenC-TT) conjugate vaccine. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
Tejedor JC et al. Antibody persistence 66 months after a booster dose of combined Haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus-toxoid (Hib-MenC-TT) conjugate vaccine. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Haemophilus Influenzae Type b trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097
ClinicalTrials.gov ID: NCT00322335
Acronym / sponsor ID: 106672
Conditions: Haemophilus Influenzae Type b, Neisseria Meningitidis
Keywords: H.influenzae type b Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Jul 2006 (actual)
Study completion: Sep 2010 (actual)
First posted: 5 May 2006 (estimated)
Results: Posted 14 Jan 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Menitorix/Pediarix Group	Experimental	Biological: Haemophilus influenzae type b- and meningococcal (vaccine), Biological: Infanrix™ pentaSubjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Active comparator	Biological: Haemophilus influenzae type b- and meningococcal (vaccine), Biological: Infanrix™ hexa, Biological: Engerix-B, Biological: NeisVac-C™, Biological: Infanrix™ IPV/HIBSubjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa/Meningitec Group	Active comparator	Biological: Infanrix™ hexa, Biological: Meningitec™Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.

Who may qualify

Ages: 31 to 33 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).

Key exclusion criteria (2 listed)

Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
History of H. influenzae type b, meningococcal serogroup C diseases.

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
Haemophilus influenzae type b- and meningococcal (vaccine)Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).	Biological	Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group, Menitorix/Pediarix Group
Infanrix™ pentaIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age	Biological	Menitorix/Pediarix Group
Infanrix™ hexaIntramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).	Biological	Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group, Infanrix hexa/Meningitec Group
Engerix-BIntramuscular injection into the thigh as a birth dose	Biological	Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
NeisVac-C™Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.	Biological	Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
Infanrix™ IPV/HIBIntramuscular injection into the thigh as primary vaccination at 4 months of age	Biological	Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
Meningitec™Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age	Biological	Infanrix hexa/Meningitec Group

Primary outcome

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
rSBA-MenC Titers
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Anti-PRP Concentrations
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Anti-PSC Concentrations
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Concentrations for anti-PSC antibody were expressed as GMCs.
Number of Subjects With Serious Adverse Events
Time frame: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Results and safety

Results posted to the registry on 14 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Menitorix/Pediarix Group	58	58
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	123	123
Infanrix Hexa/Meningitec Group	3	3

Primary outcome: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8

Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0). Number. Unit: subjects

Measure	Menitorix/Pediarix Group n = 50	Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group n = 110	Infanrix Hexa/Meningitec Group n = 52
Month 18 (N= 45; 96; 0)	44	93	0
Month 30 (N= 48; 101; 45)	39	96	31
Month 42 (N= 50; 110; 52)	39	106	33
Month 54 (N= 49; 106; 51)	38	103	33
Month 66 (N= 46; 101; 46)	38	95	28

Population analysed: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).

Primary outcome: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32

Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0). Number. Unit: subjects

Measure	Menitorix/Pediarix Group n = 50	Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group n = 110	Infanrix Hexa/Meningitec Group n = 52
Month 18 (N= 45; 96; 0)	40	93	0
Month 30 (N= 48; 101; 45)	36	94	25
Month 42 (N= 50; 110; 52)	38	100	30
Month 54 (N= 49; 106; 51)	37	100	29
Month 66 (N= 46; 101; 46)	37	88	25

Primary outcome: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128

Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0). Number. Unit: subjects

Measure	Menitorix/Pediarix Group n = 50	Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group n = 110	Infanrix Hexa/Meningitec Group n = 52
Month 18 (N= 45; 96; 0)	27	82	0
Month 30 (N= 48; 101; 45)	27	80	12
Month 42 (N= 50; 110; 52)	30	89	13
Month 54 (N= 49; 106; 51)	27	86	15
Month 66 (N= 46; 101; 46)	28	69	18

Primary outcome: rSBA-MenC Titers

Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0). Geometric mean (95% Confidence Interval). Unit: titer

Measure	Menitorix/Pediarix Group n = 50	Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group n = 110	Infanrix Hexa/Meningitec Group n = 52
Month 18 (N= 45; 96; 0)	221.5 (137.2 to 357.7)	801.1 (570.3 to 1125.3)	0 (0 to 0)
Month 30 (N= 48; 101; 45)	109.1 (61.9 to 192.3)	441.7 (309.4 to 630.6)	40.3 (21.9 to 74.1)
Month 42 (N= 50; 110; 52)	98.9 (56.7 to 172.5)	409.8 (297.7 to 564.2)	36.1 (20.4 to 63.8)
Month 54 (N= 49; 106; 51)	90.4 (52.8 to 154.8)	344.6 (255.9 to 463.9)	36.7 (21.1 to 64.0)
Month 66 (N= 46; 101; 46)	121.5 (71.0 to 207.9)	227.6 (160.2 to 323.3)	42.7 (22.3 to 81.8)

Adverse events

Time frame: From the last contact of the booster study (NCT00323050) until Month 66 after the booster dose (day 0).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menitorix/Pediarix Group	0 of 58 (0%)	0 of 0	Not reported
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	0 of 123 (0%)	0 of 0	Not reported
Infanrix Hexa/Meningitec Group	0 of 57 (0%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18536619Tejedor JC, Moro M, Merino JM, Gomez-Campdera JA, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Ruiz-Contreras J, Martin-Ancel A, Roca J, Boceta R, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 102547 Study Group. Immunogenicity and reactogenicity of a booster dose of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine given to toddlers of 13-14 months of age with antibody persistence up to 31 months of age. Pediatr Infect Dis J. 2008 Jul;27(7):579-88. doi: 10.1097/INF.0b013e31816b4561.
Background: PubMed 22828645Tejedor JC, Merino JM, Moro M, Navarro ML, Espin J, Omenaca F, Garcia-Sicilia J, Moreno-Perez D, Ruiz-Contreras J, Centeno F, Barrio F, Cabanillas L, Muro M, Esporrin C, De Torres MJ, Caubet M, Boutriau D, Miller JM, Mesaros N. Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2012 Oct;31(10):1074-7. doi: 10.1097/INF.0b013e318269433a.
BackgroundTejedor JC et al. Antibody persistence 54 months after a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus-toxoid (HibMenC-TT) conjugate vaccine. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
BackgroundTejedor JC et al. Antibody persistence 66 months after a booster dose of combined Haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus-toxoid (Hib-MenC-TT) conjugate vaccine. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

12 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 6 inclusion and 2 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Yes. Results are posted in the registry (first posted 14 Jan 2011). 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?

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 (time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)). The study lists 11 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 NCT00322335, which also lists 4 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 20 Oct 2016; AzTrials last refreshed its copy on 29 Oct 2026.