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The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T | Experimental |
| |
| Group 2: CombAct-HIBâ„¢ + OPV | Experimental |
| |
| Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX Bâ„¢ at birth) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T | Biological | 0.5 mL, Intramuscular (IM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil). | 1 month post-Dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soweto | Johannesburg | 2013 | South Africa | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21289531 | Result | Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-Hep B-PRP~T Group | Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CombAct-HIB® |
| Biological |
0.5 mL, IM |
|
| Engerix B® Pediatric | Biological | 0.5 mL, IM |
|
| 1 month post-Dose 3 |
| Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix Bâ„¢ at Birth) or CombAct Hibâ„¢ + Engerix Bâ„¢ + Oral Polio Vaccine (OPV) | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. | Day 42 before Dose 1 and 1 month post-Dose 3 |
| Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA. | Day 540 pre-booster and Day 570 post-booster |
| Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix Bâ„¢ at Birth) or CombAct Hibâ„¢ + Engerix Bâ„¢ + OPV | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. | Day 540 pre-booster and Day 570, post-booster |
| Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable. | Day 0 up to Day 7 post each dose |
| Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable. | Day 0 up to 7 post-booster vaccination |
| Bertsham |
| South Africa |
| FG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| FG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-Hep B-PRP~T Group | Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| BG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| BG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil). | Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Number | Participants | 1 month post-Dose 3 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline. | Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Number | Participants | 1 month post-Dose 3 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix Bâ„¢ at Birth) or CombAct Hibâ„¢ + Engerix Bâ„¢ + Oral Polio Vaccine (OPV) | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. | GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 42 before Dose 1 and 1 month post-Dose 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA. | Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Number | Participants | Day 540 pre-booster and Day 570 post-booster |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix Bâ„¢ at Birth) or CombAct Hibâ„¢ + Engerix Bâ„¢ + OPV | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. | GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 540 pre-booster and Day 570, post-booster |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable. | Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population. | Posted | Number | Participants | Day 0 up to Day 7 post each dose |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable. | Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population). | Posted | Number | Participants | Day 0 up to 7 post-booster vaccination |
|
Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination.
The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTaP-IPV-Hep B-PRP~T Group | Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. | 7 | 243 | 202 | 243 | ||
| EG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. | 6 | 242 | 210 | 242 | ||
| EG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. | 5 | 137 | 119 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Valve Stenosis | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Heart Disease Congenital | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Ventricular Septal Defect | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D016871 | Pasteurellaceae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625558 | DTaP-IPV-HB-PRP-T vaccine |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Anti-Diphtheria (N = 206, 206, 122) |
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| Anti-Tetanus (N = 213, 210, 122) |
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| Anti-Polio Type 1 (N = 186, 187, 104) |
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| Anti-Polio Type 2 (N = 196, 192, 113) |
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| Anti-Polio Type 3 (N = 182, 179, 98) |
|
| OG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| OG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
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|
Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age.
| OG002 | DTaP-IPV-Hep B-PRP-T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
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| OG001 |
| CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group |
Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| OG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
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Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age.
| OG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
|
|
| OG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| OG002 | DTaP-IPV-Hep B-PRP~T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
|
|
| OG001 | CombAct-Hibâ„¢ + Engerix Bâ„¢ + OPV Group | Participants received a primary series of 3 doses of commercial CombAct-Hibâ„¢ vaccine, Engerix Bâ„¢ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
| OG002 | DTaP-IPV-Hep B-PRP-T (Engerix Bâ„¢ at Birth) Group | Participants received Engerix Bâ„¢ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovaxâ„¢ and Varilrixâ„¢ vaccines at 15 to 18 months of age. |
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