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The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants receive vaccine Batch A |
|
| Group 2 | Experimental | Participants receive vaccine Batch B |
|
| Group 3 | Experimental | Participants receive vaccine Batch C |
|
| Group 4 | Active Comparator | Participants receive Infanrix hexaâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T vaccine | Biological | 0.5 mL, intramuscular (IM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies. | Day 150 (one month post-dose 3) |
| Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3. | Day 150 (one month post-dose 3) |
| Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions). | Day 150 (one month post-dose 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexaâ„¢ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Estado de México | 56613 | Mexico | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-HB-PRP~T Batch 1 | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DTaP-IPV-HB-PRP~T vaccine |
| Biological |
0.5 mL, IM |
|
| DTaP-IPV-HB-PRP~T vaccine | Biological | 0.5 mL, IM |
|
| DTaP-HBV-IPV vaccine | Biological | 0.5 mL, IM |
|
|
| Day 150 (one month post-dose 3) |
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexaâ„¢ Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability | Day 0 (pre-each vaccination) up to 7 days post-each dose |
| Estado de México |
| Mexico |
| Insurgentes Cuicuilco | Mexico |
| Monterrey | Mexico |
| Puebla City | Mexico |
| Tlalpan | 14050 | Mexico |
| FG001 |
| DTaP-IPV-HB-PRP~T Batch 2 |
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| FG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| FG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-HB-PRP~T Batch 1 | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| BG001 | DTaP-IPV-HB-PRP~T Batch 2 | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| BG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| BG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| BG004 | 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 | Months |
| |||||||||||||||
| 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 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies. | Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint. | Posted | Number | Participants | Day 150 (one month post-dose 3) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3. | Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Number | Participants | Day 150 (one month post-dose 3) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions). | Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Number | Participants | Day 150 (one month post-dose 3) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexaâ„¢ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). | Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 150 (one month post-dose 3) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexaâ„¢ Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability | Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome | Posted | Number | Participants | Day 0 (pre-each vaccination) up to 7 days post-each dose |
|
Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
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| 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-HB-PRP~T Batch 1 | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | 5 | 337 | 220 | 337 | ||
| EG001 | DTaP-IPV-HB-PRP~T Batch 2 | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | 5 | 345 | 237 | 345 | ||
| EG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | 12 | 340 | 225 | 340 | ||
| EG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | 6 | 167 | 95 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Disease Congenital | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Food Intolerance | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Infantile Spasms | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal 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 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 |
| |
| 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 |
|
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 |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000625558 | DTaP-IPV-HB-PRP-T vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Anti-PRP (N = 231, 236, 228, 119) |
|
| Anti-Diphtheria (N = 231, 236, 228, 119) |
|
| Anti-Tetanus (N = 231, 236, 227, 119) |
|
| OG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| OG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
|
|
| OG002 |
| DTaP-IPV-HB-PRP~T Batch 3 |
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| OG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
|
|
| OG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| OG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
|
|
| OG002 | DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. |
| OG003 | Infanrix Hexaâ„¢ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
|
|