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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Condition: |
Hepatitis A Virus |
| Interventions: |
Biological: Comparator: VAQTA™ (Hepatitis A vaccine) Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
|
39 clinical sites in the United States Date first participant visit: 14-Apr-2006 Date last participant visit: 25-Mar-2008 |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. |
| Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit. |
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | |
|---|---|---|
| STARTED | 330 | 323 |
| Visit 1 | 330 | 323 |
| Visit 2 | 305 | 294 |
| Visit 3 | 273 | 261 |
| Visit 4 | 262 | 240 |
| COMPLETED | 262 | 230 |
| NOT COMPLETED | 68 | 93 |
| Adverse Event | 0 | 1 |
| Lost to Follow-up | 25 | 42 |
| Protocol Violation | 3 | 8 |
| Withdraw by Participant | 20 | 20 |
| Participant Moved | 11 | 10 |
| Unspecified | 9 | 12 |
Baseline Characteristics
| Description | |
|---|---|
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. |
| Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit. |
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
330 | 323 | 653 |
|
Age [units: years] Mean ± Standard Deviation |
12.4 ± 0.80 | 12.5 ± 0.89 | 12.4 ± 0.85 |
|
Gender [units: participants] |
|||
| Female | 156 | 166 | 322 |
| Male | 174 | 157 | 331 |
Outcome Measures
| 1. Primary: | Antibody Response to Hepatitis A - Participants With a Serological Response [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] |
| 2. Primary: | Antibody Response to Varicella - Participants With a Serological Response [ 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ] |
| 3. Primary: | Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 4. Primary: | Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 5. Primary: | Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 6. Primary: | Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 7. Primary: | Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 8. Primary: | Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 9. Primary: | Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 10. Primary: | Participants With 1 or More Systemic Adverse Experience [ 6 weeks post dose 1 ] |
| 11. Primary: | Participants With 1 or More Systemic Adverse Experience [ 4 weeks post dose 2 ] |
| 12. Primary: | Participants With 1 or More Systemic Adverse Experience. [ 6 months ] |
| 13. Primary: | Participants With 1 or More Injection-site Adverse Experience [ 6 weeks post dose 1 ] |
| 14. Primary: | Participants With 1 or More Injection-site Adverse Experience [ 4 weeks post dose 2 ] |
| 15. Primary: | Participants With 1 or More Injection-site Adverse Experience [ 6 months ] |
| 16. Primary: | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 6 weeks post dose 1 ] |
| 17. Primary: | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 4 weeks post dose 2 ] |
| 18. Primary: | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 6 months ] |
| 19. Primary: | Participants With 1 or More Serious Vaccine-related Adverse Experience [ 6 weeks post dose 1 ] |
| 20. Primary: | Participants With 1 or More Serious Vaccine-related Adverse Experience [ 4 weeks post dose 2 ] |
| 21. Primary: | Participants With 1 or More Serious Vaccine-related Adverse Experience [ 6 months ] |
| 22. Primary: | Antibody Response to Hepatitis A – Geometric Mean Titer [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] |
| 23. Primary: | Antibody Response to Varicella - Geometric Mean Titer [ 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ] |
| 24. Primary: | Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 25. Primary: | Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 26. Primary: | Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 27. Primary: | Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 28. Primary: | Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 29. Primary: | Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
| 30. Primary: | Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] |
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Threshold above which other adverse events are reported | 0% |
|---|
| Description | |
|---|---|
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. |
| Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit. |
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected | 231 | 172 |
| Blood and lymphatic system disorders | ||
| Lymphadenopathy * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Ear and labyrinth disorders | ||
| Ear Pain * A # participants affected / at risk |
2/330 (0.61%) |
2/286 (0.70%) |
| Otorrhea * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Eye disorders | ||
| Conjunctivitis * A # participants affected / at risk |
3/330 (0.91%) |
4/286 (1.40%) |
| Eye Discharge * A # participants affected / at risk |
2/330 (0.61%) |
0/286 (0.00%) |
| Eye Swelling * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Gastrointestinal disorders | ||
| Abdominal Pain Upper * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Constipation * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Diarrhea * A # participants affected / at risk |
16/330 (4.85%) |
8/286 (2.80%) |
| Flatulence * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Gastroesophageal Reflux Disease * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Nausea * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Oral Pain * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Teething * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Vomiting * A # participants affected / at risk |
10/330 (3.03%) |
6/286 (2.10%) |
| General disorders | ||
| Body Temperature * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Fatigue * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Irritability * A # participants affected / at risk |
24/330 (7.27%) |
17/286 (5.94%) |
| Pain * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Pyrexia * A # participants affected / at risk |
126/330 (38.18%) |
53/286 (18.53%) |
| Bruising, Injection site for VAQTA™ * A # participants affected / at risk |
6/330 (1.82%) |
7/286 (2.45%) |
| Erythema, Injection site for VAQTA™ † A # participants affected / at risk |
45/330 (13.64%) |
51/286 (17.83%) |
| Haemorrhage, Injection site for VAQTA™ * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Nodule, Injection site for VAQTA™ * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Pain, Injection site for VAQTA™ † A # participants affected / at risk |
86/330 (26.06%) |
73/286 (25.52%) |
| Rash, Injection site for VAQTA™ * A # participants affected / at risk |
5/330 (1.52%) |
1/286 (0.35%) |
| Reaction, Injection site for VAQTA™ * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Swelling, Injection site for VAQTA™ † A # participants affected / at risk |
32/330 (9.70%) |
38/286 (13.29%) |
| Warmth, Injection site for VAQTA™ * A # participants affected / at risk |
2/330 (0.61%) |
0/286 (0.00%) |
| Immune system disorders | ||
| Drug Hypersensitivity * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Multiple Allergies * A # participants affected / at risk |
3/330 (0.91%) |
0/286 (0.00%) |
| Seasonal Allergy * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Infections and infestations | ||
| Acute Sinusitis * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Adenovirus Infection * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Body Tinea * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Bronchitis * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Candida Nappy Rash * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Candidiasis * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Conjunctivitis Bacterial * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Conjunctivitis Infective * A # participants affected / at risk |
3/330 (0.91%) |
1/286 (0.35%) |
| Conjunctivitis Viral * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Croup Infectious * A # participants affected / at risk |
3/330 (0.91%) |
4/286 (1.40%) |
| Ear Infection * A # participants affected / at risk |
6/330 (1.82%) |
1/286 (0.35%) |
| Enterobiasis * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Eye Infection * A # participants affected / at risk |
2/330 (0.61%) |
0/286 (0.00%) |
| Gastroenteritis * A # participants affected / at risk |
3/330 (0.91%) |
2/286 (0.70%) |
| Gastroenteritis Viral * A # participants affected / at risk |
2/330 (0.61%) |
3/286 (1.05%) |
| Impetigo * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Influenza * A # participants affected / at risk |
1/330 (0.30%) |
2/286 (0.70%) |
| Mycoplasma Infection * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Nasopharyngitis * A # participants affected / at risk |
12/330 (3.64%) |
7/286 (2.45%) |
| Otitis Media * A # participants affected / at risk |
25/330 (7.58%) |
17/286 (5.94%) |
| Otitis Media Acute * A # participants affected / at risk |
2/330 (0.61%) |
3/286 (1.05%) |
| Pharyngitis * A # participants affected / at risk |
3/330 (0.91%) |
3/286 (1.05%) |
| Pharyngitis Streptococcal * A # participants affected / at risk |
2/330 (0.61%) |
3/286 (1.05%) |
| Pharyngotonsillitis * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Pneumonia * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Respiratory Syncytial Virus Infection * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Rhinitis * A # participants affected / at risk |
7/330 (2.12%) |
7/286 (2.45%) |
| Roseola * A # participants affected / at risk |
5/330 (1.52%) |
1/286 (0.35%) |
| Sinusitis * A # participants affected / at risk |
3/330 (0.91%) |
0/286 (0.00%) |
| Skin Infection * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Tinea Pedis * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Upper Respiratory Tract Infection * A # participants affected / at risk |
34/330 (10.30%) |
19/286 (6.64%) |
| Viraemia * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Viral Infection * A # participants affected / at risk |
9/330 (2.73%) |
1/286 (0.35%) |
| Viral Pharyngitis * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Viral Skin Infection * A # participants affected / at risk |
2/330 (0.61%) |
2/286 (0.70%) |
| Viral upper respiratory tract Infection * A # participants affected / at risk |
0/330 (0.00%) |
2/286 (0.70%) |
| Injury, poisoning and procedural complications | ||
| Arthropod Bite * A # participants affected / at risk |
2/330 (0.61%) |
2/286 (0.70%) |
| Arthropod Sting * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Contusion * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Head Injury * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Lower Limb Fracture * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Sunburn * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Thermal Burn * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Metabolism and nutrition disorders | ||
| Anorexia * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Decreased Appetite * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Hypervitaminosis A * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Iron Deficiency * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Musculoskeletal and connective tissue disorders | ||
| Muscular Weakness * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Pain In Extremity * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Nervous system disorders | ||
| Febrile Convulsion * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Headache * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Lethargy * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Tremor * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Psychiatric disorders | ||
| Crying * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Insomnia * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Restlessness * A # participants affected / at risk |
0/330 (0.00%) |
2/286 (0.70%) |
| Sleep Disorder * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Reproductive system and breast disorders | ||
| Penile Discharge * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Bronchial Hyperreactivity * A # participants affected / at risk |
1/330 (0.30%) |
2/286 (0.70%) |
| Cough * A # participants affected / at risk |
15/330 (4.55%) |
9/286 (3.15%) |
| Nasal Congestion * A # participants affected / at risk |
7/330 (2.12%) |
3/286 (1.05%) |
| Paranasal Sinus Hypersecretion * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Pharyngolaryngeal Pain * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Respiratory Tract Congestion * A # participants affected / at risk |
3/330 (0.91%) |
2/286 (0.70%) |
| Rhinalgia * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Rhinitis Allergic * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Rhinorrhea * A # participants affected / at risk |
16/330 (4.85%) |
9/286 (3.15%) |
| Sinus Congestion * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Sneezing * A # participants affected / at risk |
2/330 (0.61%) |
1/286 (0.35%) |
| Wheezing * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Dermatitis Allergic * A # participants affected / at risk |
1/330 (0.30%) |
2/286 (0.70%) |
| Dermatitis Atopic * A # participants affected / at risk |
1/330 (0.30%) |
1/286 (0.35%) |
| Dermatitis Contact * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Dermatitis Diaper * A # participants affected / at risk |
26/330 (7.88%) |
9/286 (3.15%) |
| Eczema * A # participants affected / at risk |
3/330 (0.91%) |
3/286 (1.05%) |
| Erythema * A # participants affected / at risk |
2/330 (0.61%) |
0/286 (0.00%) |
| Erythema Multiforme * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Rash * A # participants affected / at risk |
10/330 (3.03%) |
4/286 (1.40%) |
| Rash Macular * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Rash Maculo-papular * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Rash Morbilliform * A # participants affected / at risk |
8/330 (2.42%) |
1/286 (0.35%) |
| Rash Rubelliform * A # participants affected / at risk |
1/330 (0.30%) |
0/286 (0.00%) |
| Rash Vesicular * A # participants affected / at risk |
4/330 (1.21%) |
2/286 (0.70%) |
| Urticaria * A # participants affected / at risk |
0/330 (0.00%) |
1/286 (0.35%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| * | Indicates events were collected by non-systematic assessment. |
| A | Term from vocabulary, MedDRA 11.0 |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2005_075, V251-067 |
| Study First Received: | April 7, 2006 |
| Results First Received: | March 24, 2009 |
| Last Updated: | November 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00312858 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
