Neisseria MeningitidisPhase 3NCT01839188
Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
A Phase 3 study testing PR5I, Pediacel® and NeisVac-C® in people with Neisseria Meningitidis and Bacterial Infections, run by MCM Vaccines B.V..
Trial summary
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule To… Read more about this study
- Who is it for?
- Ages 46 to 76 daysHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- What is being tested?
- PR5I, Pediacel® and NeisVac-C®
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 19 Mar 2014
- 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 46 to 76 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant 46 to 74 days (both inclusive)
- Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
- Parent(s)/legal representative able to comply with the study procedures
Who cannot join
- Participation in any study with an investigational compound or device since birth
- History of congenital or acquired immunodeficiency
- Chronic illness that could interfere with study conduct or completion
- Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
- Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
- History or maternal history of HBsAg seropositivity
Show all 12Show fewer
- Coagulation disorder that contraindicate intramuscular injection
- History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
- History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
- Receipt of immune globulin, blood or blood-derived products since birth
- Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
About this study
Official title: A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
Read more
- To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
- To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule
Secondary objectives
- To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
- To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
- To describe the safety profile after each dose of study vaccines administered
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Being tested
- PR5I, Pediacel®, NeisVac-C®, RotaTeq®, Prevenar 13®
- Medical subject headings
- Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR5IBiological
Also called V419, Vaxelis®, DTaP-HB-IPV-Hib
Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.
Pediacel®Biological
Also called DTaP-IPV-Hib
Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.
NeisVac-C®Biological
Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
RotaTeq®Biological
Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.
Prevenar 13®Biological
Also called PCV-13
Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
| Study group | Role | What they receive |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Experimental | [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. Receives: Biological: PR5I; Biological: Pediacel®; Biological: NeisVac-C®; Biological: RotaTeq®; Biological: Prevenar 13® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Measured: Month 5 (one month after receiving Vaccination 3)
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Measured: Month 5 (one month after receiving Vaccination 3)
Secondary outcomes (17)
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL).
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL).
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2\&3. The unit of measure is ELISA Units/mL (EU/mL).
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, \& 3 (IPV1, IPV2, \& IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus.
Measured: Month 5 (one month after receiving Vaccination 3)
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds:
- For anti-PRP Abs (Hib capsular polysaccharide) - Response defined as a concentration ≥1 µg/mL (measured by RIA);
- For anti-D Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by MIT);
- For anti-T Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by ELISA);
- For anti-IPV1, anti-IPV2, and anti-IPV3 Abs - Response defined as a titer ≥ 8 (measured by MIT).
The percentage of participants considered as responding to the individual antigen (per the response threshold[s]) were assessed.
Measured: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies
Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain.
Measured: Month 3 (one month after receiving Vaccination 2)
Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8
The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA).
Measured: Month 3 (one month after receiving Vaccination 2)
Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination
The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment.
Measured: Up to Day 5 following each vaccination
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination.
Measured: Up to Day 5 following each vaccination
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Measured: Up to Day 5 following each vaccination
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination.
Measured: Up to Day 15 following each vaccination
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Measured: Up to Day 15 following each vaccination
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination.
Measured: Up to Day 5 following each vaccination
Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)
The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination.
Measured: Up to Day 15 following each vaccination
Number of Participants Experiencing a Serious Adverse Event (SAE)
An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.
Measured: Up to ~6 months (at any time during the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study start1 May 2013
- Primary completion19 Mar 2014
- Study completion19 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neisseria MeningitidisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- MCM Vaccines B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839188
- Sponsor's protocol ID
- V419-010
- Other IDs
- 2012-004221-25, PRI02C, V419-010
- Status last verified
- Feb 2019
- First submitted
- 19 Apr 2013
- Last updated
- 25 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.
PubMed 28583305
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.
- ClinicalTrials.gov ID
- NCT01839188
- Acronym / sponsor ID
- V419-010
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- MCM Vaccines B.V.Industry (pharma, biotech, devices)
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Merck Sharp & Dohme LLC
- Study start
- 1 May 2013 (actual)
- Primary completion
- 19 Mar 2014 (actual)
- Study completion
- 19 Mar 2014 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 25 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
- To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
- To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule
Secondary objectives
- To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
- To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
- To describe the safety profile after each dose of study vaccines administered
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Experimental | Biological: PR5I, Biological: Pediacel®, Biological: NeisVac-C®, Biological: RotaTeq®, Biological: Prevenar 13®[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
Who may qualify
- Ages
- 46 to 76 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infant 46 to 74 days (both inclusive)
- Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
- Parent(s)/legal representative able to comply with the study procedures
Key exclusion criteria (12 listed)
- Participation in any study with an investigational compound or device since birth
- History of congenital or acquired immunodeficiency
- Chronic illness that could interfere with study conduct or completion
- Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
- Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
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 |
|---|---|---|
| PR5IAlso: V419, Vaxelis®, DTaP-HB-IPV-HibHexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age. | Biological | PR5I (V1); Pediacel® (V2); PR5I (V3) |
| Pediacel®Also: DTaP-IPV-HibPentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age. | Biological | PR5I (V1); Pediacel® (V2); PR5I (V3) |
| NeisVac-C®Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. | Biological | PR5I (V1); Pediacel® (V2); PR5I (V3) |
| RotaTeq®Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying. | Biological | PR5I (V1); Pediacel® (V2); PR5I (V3) |
| Prevenar 13®Also: PCV-13Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. | Biological | PR5I (V1); Pediacel® (V2); PR5I (V3) |
Primary outcome
Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
Time frame: Month 5 (one month after receiving Vaccination 3)
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
Time frame: Month 5 (one month after receiving Vaccination 3)
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
17 secondary outcomes
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Time frame: Month 5 (one month after receiving Vaccination 3)
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Time frame: Month 5 (one month after receiving Vaccination 3)
Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies
Time frame: Month 3 (one month after receiving Vaccination 2)
Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8
Time frame: Month 3 (one month after receiving Vaccination 2)
Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination
Time frame: Up to Day 5 following each vaccination
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Time frame: Up to Day 5 following each vaccination
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Time frame: Up to Day 5 following each vaccination
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Time frame: Up to Day 15 following each vaccination
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Time frame: Up to Day 15 following each vaccination
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Time frame: Up to Day 5 following each vaccination
Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)
Time frame: Up to Day 15 following each vaccination
Number of Participants Experiencing a Serious Adverse Event (SAE)
Time frame: Up to ~6 months (at any time during the study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28583305Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PR5I, Pediacel® and NeisVac-C® in people with Neisseria Meningitidis and Bacterial Infections, run by MCM Vaccines B.V..
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 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 25 Feb 2019). 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 With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL (time frame: Month 5 (one month after receiving Vaccination 3)). The study lists 2 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 NCT01839188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.